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Prednisone
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Corticosteroid Hormone Receptor Agonists [MoA] | MoA | All 215 members |
| Corticosteroid [EPC] | EPC | All 215 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 208412-001 | PREDNISONE | TABLET | PREDNISONE | Prescription | AB | ||
| 208412-002 | PREDNISONE | TABLET | PREDNISONE | Prescription | AB | ||
| 208412-003 | PREDNISONE | TABLET | PREDNISONE | Prescription | AB | ||
| 208412-004 | PREDNISONE | TABLET | PREDNISONE | Prescription | AB | ||
| 208412-005 | PREDNISONE | TABLET | PREDNISONE | Prescription | AB |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 7 | Labeling | Approved | June 5, 2024 | Standard |
| Original application | 1 | Approved | February 11, 2021 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260908). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingINDICATIONS AND USAGE Prednisone tablets USP are indicated in the following conditions: Endocrine disorders : primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, nonsuppurative thyroiditis, hypercalcemia associated with cancer. Rheumatic disorders : as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis; posttraumatic osteoarthritis; synovitis of osteoarthritis; epicondylitis. Collagen Diseases : during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, acute rheumatic carditis. Dermatologic Diseases: pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, severe psoriasis, severe seborrheic dermatitis. Allergic States: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis, serum sickness, bronchial asthma, contact dermatitis, atopic dermatitis, drug hypersensitivity reactions. Ophthalmic Diseases : severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as: allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, herpes zoster ophthalmicus, iritis and iridocyclitis, chorioretinitis, anterior segment inflammation, diffuse posterior uveitis and choroiditis, optic neuritis, sympathetic ophthalmia. Respiratory Diseases : symptomatic sarcoidosis, Loeffler's syndrome not manageable by other means, berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, aspiration pneumonitis. Hematologic Disorders: idiopathic thrombocytopenic purpura in adults, secondary thrombocytopenia in adults, acquired (autoimmune) hemolytic anemia, erythroblastopenia (RBC anemia), congenital (erythroid) hypoplastic anemia. Neoplastic Diseases : for palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous States: to induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Gastrointestinal Diseases: to tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. Miscellaneous: tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement. In addition to the above indications, prednisone tablets are indicated for systemic dermatomyositis (polymyositis).
Dosage and Administration
openFDA Drug LabelingDOSAGE AND ADMINISTRATION Gastric irritation may be reduced if taken before, during, or immediately after meals or with food or milk. The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity (am) for single dose administration. Therefore, it is recommended that prednisone be administered in the morning prior to 9 am and when large doses are given, administration of antacids between meals to help prevent peptic ulcers. Multiple dose therapy should be evenly distributed in evenly spaced intervals throughout the day. Dietary salt restriction may be advisable in patients. Do not stop taking this medicine without first talking to your doctor. Avoid abrupt withdraw of therapy. The initial dosage of PredniSONE tablets may vary from 5 mg to 60 mg per day, depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice, while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, PredniSONE should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small increments at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient jexposure to stressful situations not directly related to the disease entity under treatment; in this latter situation, it may be necessary to increase the dosage of PredniSONE for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly. Multiple Sclerosis In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.) Alternate Day Therapy Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring longterm pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children. The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day. A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal ( …
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS Prednisone tablets and oral solutions are contraindicated in systemic fungal infections and known hypersensitivity to components.
Warnings and Cautions
openFDA Drug Labeling5. Warnings and Precautions In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated. Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used. Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses. Usage in pregnancy: Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy, should be carefully observed for signs of hypoadrenalism. Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. While on corticosteroid therapy patients should not be vaccinated against smallpox. Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially on high dose, because of possible hazards of neurological complications and a lack of antibody response. The use of Prednisone Tablets, USP in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate anti-tuberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis. Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella-zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered. General Precautions Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. The lowest possible dose of corticosteroid should b …
Warnings
openFDA Drug LabelingWARNINGS General Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS: Allergic Reactions ). Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during and after the stressful situation. Cardio-Renal Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients. Endocrine Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment. Adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased. Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in dosage. Infection General Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function. 1 These infections may be mild, but may be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 Corticosteroids may also mask some signs of current infection. Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions : Amphotericin B Injection and Potassium-Depleting Agents ). Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma . It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Corticosteroids should not be used in cerebral malaria. Tuberculosis The use of prednisone in active tuberculosis should be restricted to those cases of fulminating …
Adverse Reactions
openFDA Drug LabelingADVERSE REACTIONS (listed alphabetically, under each subsection) The following adverse reactions have been reported with prednisone or other corticosteroids: Allergic Reactions anaphylactoid or hypersensitivity reactions, anaphylaxis, angioedema. Cardiovascular System bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, ECG changes caused by potassium deficiency, edema, fat embolism, hypertension or aggravation of hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS : Cardio-Renal ), necrotizing angiitis, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis. Dermatologic acne, acneiform eruptions, allergic dermatitis, alopecia, angioedema, angioneurotic edema, atrophy and thinning of skin, dry scaly skin, ecchymoses and petechiae (bruising), erythema, facial edema, hirsutism, impaired wound healing, increased sweating, Karposi’s sarcoma (see PRECAUTIONS: General Precautions ), lupus erythematosus-like lesions, perineal irritation, purpura, rash, striae, subcutaneous fat atrophy, suppression of reactions to skin tests, striae, telangiectasis, thin fragile skin, thinning scalp hair, urticaria. Endocrine Adrenal insufficiency-greatest potential caused by high potency glucocorticoids with long duration of action (associated symptoms include; arthralgias, buffalo hump, dizziness, life-threatening hypotension, nausea, severe tiredness or weakness), amenorrhea, postmenopausal bleeding or other menstrual irregularities, decreased carbohydrate and glucose tolerance, development of cushingoid state, diabetes mellitus (new onset or manifestations of latent), glycosuria, hyperglycemia, hypertrichosis, hyperthyroidism (see WARNINGS : Endocrine ), hypothyroidism, increased requirements for insulin or oral hypoglycemic agents in diabetics, lipids abnormal, moon face, negative nitrogen balance caused by protein catabolism, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery or illness) (see WARNINGS : Endocrine ), suppression of growth in pediatric patients. Fluid and Electrolyte Disturbances congestive heart failure in susceptible patients, fluid retention, hypokalemia, hypokalemic alkalosis, metabolic alkalosis, hypotension or shock-like reaction, potassium loss, sodium retention with resulting edema. Gastrointestinal abdominal distention, abdominal pain,anorexia which may result in weight loss, constipation, diarrhea, elevation in serum liver enzyme levels (usually reversible upon discontinuation), gastric irritation, hepatomegaly, increased appetite and weight gain, nausea, oropharyngeal candidiasis, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis, vomiting. Hematologic anemia, neutropenia (including febrile neutropenia). Metabolic negative nitrogen balance due to protein catabolism. Musculoskeletal arthralgias, aseptic necrosis of femoral and humeral heads, increase risk of fracture, loss of muscle mass, muscle weakness, myalgias, osteopenia, osteoporosis (see PRECAUTIONS : Musculoskeletal ), pathologic fracture of long bones, steroid myopathy, tendon rupture (particularly of the Achilles tendon), vertebral compression fractures. Neurological/Psychiatric amnesia, anxiety, benign intracranial hypertension, convulsions, delirium, dementia (characterized by deficits in memory retention, attention, concentration, mental speed and efficiency, and occupational performance), depression, dizziness, EEG abnormalities, emotional instability and irritability, euphoria, hallucinations, headache, impaired cognition, incidence of severe psychiatric symptoms, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of trea …
Drug Interactions
openFDA Drug LabelingDrug Interactions Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure. Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions: Hepatic Enzyme Inducers, Inhibitors and Substrates ). Anticholinesterases Concomitant use of anticholinesterase agents (e.g., neostigmine, pyridostigmine ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated. Anticoagulants, Oral Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect. Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required. Antitubercular drugs Serum concentrations of isoniazid may be decreased. Bupropion Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed. Cholestyramine Cholestyramine may increase the clearance of corticosteroids. Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use. Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia. Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect. Fluoroquinolones Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ciprofloxacin, levofloxacin ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones. Hepatic Enzyme Inducers, Inhibitors and Substrates Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics such as erythromycin ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin ) may increase their clearance, resulting in decreased plasma concentration. Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal. Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylate …
Mechanism of Action
openFDA Drug LabelingACTIONS Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs, such as prednisone, are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids, such as prednisone, cause profound and varied metabolic effects. In addition, they modify the body's immune response to diverse stimuli.
Description
openFDA Drug LabelingDESCRIPTION Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone, USP is a white to partially white, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below: C 21 H 26 O 5 M.W. 358.44 Each tablet, for oral administration, contains 1, 2.5, 5, 10, 20, or 50 mg of prednisone. PredniSONE Oral Solution contains 5 mg prednisone per 5 mL, and PredniSONE Intensol TM Oral Solution (Concentrate) contains 5 mg prednisone per mL. Inactive Ingredients: PredniSONE Tablets, USP contain the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate and stearic acid (1 mg, 2.5 mg, and 5 mg only). PredniSONE Oral Solution, USP contains alcohol 5% and the following inactive ingredients: anhydrous citric acid, edetate disodium, fructose, hydrochloric acid, maltol, peppermint oil, polysorbate 80, propylene glycol, saccharin sodium, sodium benzoate, vanilla flavor and purified water. PredniSONE IntensolTM Oral Solution (Concentrate) contains alcohol 30% and the following inactive ingredients: anhydrous citric acid, poloxamer 188, propylene glycol and purified water. Chemical Structure
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Prednisone Tablets USP, 2.5 mg are yellow colored, round, biconvex tablets, scored on one side and “PE”, “11” on other side. They are supplied as follows: Bottles of 18 NDC 87063-042-18 (repackaged from NDC 59651-485-XX) Bottles of 20 NDC 87063-042-20 (repackaged from NDC 59651-485-XX) Bottles of 21 NDC 87063-042-21 (repackaged from NDC 59651-485-XX) Bottles of 30 NDC 87063-042-30 (repackaged from NDC 59651-485-XX) Bottles of 60 NDC 87063-042-60 (repackaged from NDC 59651-485-XX) Bottles of 90 NDC 87063-042-90 (repackaged from NDC 59651-485-XX) Bottles of 100 NDC 87063-042-01 (relabeled from NDC 59651-485-01) 10x10 Unit-dose Tablets NDC 87063-042-78 (relabeled from NDC 59651-485-78) Prednisone Tablets USP, 5 mg are orange colored, round, biconvex tablets, scored on one side and “PI”, “5” on other side. They are supplied as follows: Bottles of 18 NDC 87063-043-18 (repackaged from NDC 59651-486-XX) Bottles of 20 NDC 87063-043-20 (repackaged from NDC 59651-486-XX) Bottles of 21 NDC 87063-043-21 (repackaged from NDC 59651-486-XX) Bottles of 30 NDC 87063-043-30 (repackaged from NDC 59651-486-XX) Bottles of 60 NDC 87063-043-60 (repackaged from NDC 59651-486-XX) Bottles of 90 NDC 87063-043-90 (repackaged from NDC 59651-486-XX) Bottles of 100 NDC 87063-043-01 (relabeled from NDC 59651-486-01) 10x10 Unit-dose Tablets NDC 87063-043-78 (relabeled from NDC 59651-486-78) Prednisone Tablets USP, 10 mg are white to off-white, round, biconvex tablets, scored on one side and “PI”, “10” on other side. They are supplied as follows: Bottles of 18 NDC 87063-044-18 (repackaged from NDC 59651-487-XX) Bottles of 20 NDC 87063-044-20 (repackaged from NDC 59651-487-XX) Bottles of 21 NDC 87063-044-21 (repackaged from NDC 59651-487-XX) Bottles of 30 NDC 87063-044-30 (repackaged from NDC 59651-487-XX) Bottles of 60 NDC 87063-044-60 (repackaged from NDC 59651-487-XX) Bottles of 90 NDC 87063-044-90 (repackaged from NDC 59651-487-XX) Bottles of 100 NDC 87063-044-01 (relabeled from NDC 59651-487-01) 10x10 Unit-dose Tablets NDC 87063-044-78 (relabeled from NDC 59651-487-78) Prednisone Tablets USP, 20 mg are white to off-white, round, biconvex tablets, scored on one side and “PI”, “20” on other side. They are supplied as follows: Bottles of 18 NDC 87063-045-18 (repackaged from NDC 59651-488-XX) Bottles of 20 NDC 87063-045-20 (repackaged from NDC 59651-488-XX) Bottles of 21 NDC 87063-045-21 (repackaged from NDC 59651-488-XX) Bottles of 30 NDC 87063-045-30 (repackaged from NDC 59651-488-XX) Bottles of 60 NDC 87063-045-60 (repackaged from NDC 59651-488-XX) Bottles of 90 NDC 87063-045-90 (repackaged from NDC 59651-488-XX) Bottles of 100 NDC 87063-045-01 (relabeled from NDC 59651-488-01) 10x10 Unit-dose Tablets NDC 87063-045-78 (relabeled from NDC 59651-488-78) Prednisone Tablets USP, 50 mg are white to off-white, round, biconvex tablets, scored on one side and “PI”, “50” on other side. They are supplied as follows: Bottles of 18 NDC 87063-048-18 (repackaged from NDC 59651-489-XX) Bottles of 20 NDC 87063-048-20 (repackaged from NDC 59651-489-XX) Bottles of 21 NDC 87063-048-21 (repackaged from NDC 59651-489-XX) Bottles of 30 NDC 87063-048-30 (repackaged from NDC 59651-489-XX) Bottles of 60 NDC 87063-048-60 (repackaged from NDC 59651-489-XX) Bottles of 90 NDC 87063-048-90 (repackaged from NDC 59651-489-XX) Bottles of 100 NDC 87063-048-01 (relabeled from NDC 59651-489-01) 10x10 Unit-dose Tablets NDC 87063-048-78 (relabeled from NDC 59651-489-78) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, child-resistant container as defined in the USP/NF. PROTECT FROM MOISTURE. Relabeled and Repackaged by: Enovachem PHARMACEUTICALS Torrance, CA 90501
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: PREDNISONE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Recalls
Source: FDA Enforcement| Classification | Reported | Firm | Reason | Status |
|---|---|---|---|---|
| Class II | August 17, 2022 | Strides Pharma Inc. | Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets | Terminated |
| Class III | March 25, 2020 | Par Pharmaceutical Inc. | Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg | Terminated |
| Class II | October 12, 2016 | West-Ward Pharmaceutical | Failed Tablet/Capsule Specifications: Discovery of an underweight tablet. | Terminated |
| Class III | August 21, 2013 | Boehringer Ingelheim Roxane Inc | Labeling: Missing Label; missing label on blister card | Terminated |
| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-0439-0 | 50090-0439 | A-S Medication Solutions | 21 TABLET in 1 BOX, UNIT-DOSE (50090-0439-0) | June 29, 2016 |
| 50090-1001-0 | 50090-1001 | A-S Medication Solutions | 21 TABLET in 1 BOX, UNIT-DOSE (50090-1001-0) | November 28, 2014 |
| 50090-1002-0 | 50090-1002 | A-S Medication Solutions | 48 TABLET in 1 BOX, UNIT-DOSE (50090-1002-0) | November 28, 2014 |
| 50090-2786-0 | 50090-2786 | A-S Medication Solutions | 21 TABLET in 1 BOTTLE (50090-2786-0) | January 17, 2017 |
| 50090-2789-1 | 50090-2789 | A-S Medication Solutions | 10 TABLET in 1 BOTTLE (50090-2789-1) | October 12, 2017 |
| 50090-2789-2 | 50090-2789 | A-S Medication Solutions | 21 TABLET in 1 BOTTLE (50090-2789-2) | October 12, 2017 |
| 50090-2789-3 | 50090-2789 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-2789-3) | October 18, 2017 |
| 50090-2789-5 | 50090-2789 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-2789-5) | January 18, 2017 |
| 50090-2789-9 | 50090-2789 | A-S Medication Solutions | 18 TABLET in 1 BOTTLE, PLASTIC (50090-2789-9) | November 28, 2014 |
| 50090-2804-0 | 50090-2804 | A-S Medication Solutions | 20 TABLET in 1 BOTTLE (50090-2804-0) | January 20, 2017 |
| 50090-2804-1 | 50090-2804 | A-S Medication Solutions | 12 TABLET in 1 BOTTLE (50090-2804-1) | October 24, 2017 |
| 50090-2804-2 | 50090-2804 | A-S Medication Solutions | 6 TABLET in 1 BOTTLE (50090-2804-2) | May 9, 2018 |
| 50090-2804-5 | 50090-2804 | A-S Medication Solutions | 14 TABLET in 1 BOTTLE (50090-2804-5) | October 18, 2017 |
| 50090-2804-7 | 50090-2804 | A-S Medication Solutions | 15 TABLET in 1 BOTTLE (50090-2804-7) | October 13, 2017 |
| 50090-3137-0 | 50090-3137 | A-S Medication Solutions | 10 TABLET in 1 BOTTLE (50090-3137-0) | October 2, 2020 |
| 50090-3137-1 | 50090-3137 | A-S Medication Solutions | 15 TABLET in 1 BOTTLE (50090-3137-1) | September 6, 2019 |
| 50090-3137-2 | 50090-3137 | A-S Medication Solutions | 21 TABLET in 1 BOTTLE (50090-3137-2) | September 13, 2017 |
| 50090-3137-4 | 50090-3137 | A-S Medication Solutions | 50 TABLET in 1 BOTTLE (50090-3137-4) | September 10, 2019 |
| 50090-3137-5 | 50090-3137 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-3137-5) | September 19, 2017 |
| 50090-3137-7 | 50090-3137 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-3137-7) | October 2, 2020 |
| 50090-3137-8 | 50090-3137 | A-S Medication Solutions | 40 TABLET in 1 BOTTLE (50090-3137-8) | October 2, 2020 |
| 50090-3354-0 | 50090-3354 | A-S Medication Solutions | 21 TABLET in 1 BOTTLE, PLASTIC (50090-3354-0) | November 28, 2014 |
| 50090-3354-1 | 50090-3354 | A-S Medication Solutions | 50 TABLET in 1 BOTTLE (50090-3354-1) | January 31, 2018 |
| 50090-3354-3 | 50090-3354 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-3354-3) | February 16, 2018 |
| 50090-3354-4 | 50090-3354 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE, PLASTIC (50090-3354-4) | November 28, 2014 |
| 50090-3354-7 | 50090-3354 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-3354-7) | January 30, 2018 |
| 50090-3361-4 | 50090-3361 | A-S Medication Solutions | 40 TABLET in 1 BOTTLE (50090-3361-4) | February 2, 2018 |
| 50090-3361-6 | 50090-3361 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-3361-6) | March 26, 2018 |
| 50090-5202-0 | 50090-5202 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-5202-0) | October 2, 2020 |
| 50090-5202-1 | 50090-5202 | A-S Medication Solutions | 20 TABLET in 1 BOTTLE (50090-5202-1) | October 2, 2020 |
| 50090-5814-0 | 50090-5814 | A-S Medication Solutions | 21 TABLET in 1 BOTTLE (50090-5814-0) | October 18, 2021 |
| 50090-5814-1 | 50090-5814 | A-S Medication Solutions | 50 TABLET in 1 BOTTLE (50090-5814-1) | October 18, 2021 |
| 50090-5814-3 | 50090-5814 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-5814-3) | October 18, 2021 |
| 50090-5814-4 | 50090-5814 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-5814-4) | October 18, 2021 |
| 50090-5814-7 | 50090-5814 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-5814-7) | October 18, 2021 |
| 50090-6122-1 | 50090-6122 | A-S Medication Solutions | 10 TABLET in 1 BOTTLE (50090-6122-1) | September 30, 2022 |
| 50090-6122-2 | 50090-6122 | A-S Medication Solutions | 21 TABLET in 1 BOTTLE (50090-6122-2) | September 30, 2022 |
| 50090-6122-3 | 50090-6122 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-6122-3) | September 30, 2022 |
| 50090-6122-5 | 50090-6122 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-6122-5) | September 30, 2022 |
| 50090-6122-9 | 50090-6122 | A-S Medication Solutions | 18 TABLET in 1 BOTTLE (50090-6122-9) | September 30, 2022 |
| 50090-6123-0 | 50090-6123 | A-S Medication Solutions | 20 TABLET in 1 BOTTLE (50090-6123-0) | September 30, 2022 |
| 50090-6123-1 | 50090-6123 | A-S Medication Solutions | 12 TABLET in 1 BOTTLE (50090-6123-1) | September 30, 2022 |
| 50090-6123-2 | 50090-6123 | A-S Medication Solutions | 6 TABLET in 1 BOTTLE (50090-6123-2) | September 30, 2022 |
| 50090-6123-5 | 50090-6123 | A-S Medication Solutions | 14 TABLET in 1 BOTTLE (50090-6123-5) | September 30, 2022 |
| 50090-6123-7 | 50090-6123 | A-S Medication Solutions | 15 TABLET in 1 BOTTLE (50090-6123-7) | September 30, 2022 |
| 50090-6225-0 | 50090-6225 | A-S Medication Solutions | 8 TABLET in 1 BOTTLE (50090-6225-0) | November 14, 2022 |
| 50090-6259-0 | 50090-6259 | A-S Medication Solutions | 21 TABLET in 1 BOTTLE (50090-6259-0) | December 7, 2022 |
| 50090-6376-0 | 50090-6376 | A-S Medication Solutions | 8 TABLET in 1 BOTTLE (50090-6376-0) | February 17, 2023 |
| 50090-6619-0 | 50090-6619 | A-S Medication Solutions | 21 TABLET in 1 BOTTLE (50090-6619-0) | August 24, 2023 |
| 50090-6619-1 | 50090-6619 | A-S Medication Solutions | 50 TABLET in 1 BOTTLE (50090-6619-1) | August 24, 2023 |
| 50090-6619-3 | 50090-6619 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-6619-3) | August 24, 2023 |
| 50090-6619-4 | 50090-6619 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-6619-4) | August 24, 2023 |
| 50090-6619-7 | 50090-6619 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-6619-7) | August 24, 2023 |
| 50090-6621-6 | 50090-6621 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-6621-6) | August 24, 2023 |
| 50090-6623-0 | 50090-6623 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-6623-0) | August 24, 2023 |
| 50090-7023-0 | 50090-7023 | A-S Medication Solutions | 100 BLISTER PACK in 1 CARTON (50090-7023-0) / 1 TABLET in 1 BLISTER PACK | January 8, 2024 |
| 50090-7024-0 | 50090-7024 | A-S Medication Solutions | 10 TABLET in 1 BOTTLE (50090-7024-0) | January 8, 2024 |
| 50090-7024-1 | 50090-7024 | A-S Medication Solutions | 15 TABLET in 1 BOTTLE (50090-7024-1) | January 8, 2024 |
| 50090-7024-2 | 50090-7024 | A-S Medication Solutions | 21 TABLET in 1 BOTTLE (50090-7024-2) | January 8, 2024 |
| 50090-7024-4 | 50090-7024 | A-S Medication Solutions | 50 TABLET in 1 BOTTLE (50090-7024-4) | January 8, 2024 |
| 50090-7024-5 | 50090-7024 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-7024-5) | January 8, 2024 |
| 50090-7024-8 | 50090-7024 | A-S Medication Solutions | 40 TABLET in 1 BOTTLE (50090-7024-8) | January 8, 2024 |
| 50090-7025-0 | 50090-7025 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-7025-0) | January 8, 2024 |
| 50090-7124-0 | 50090-7124 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7124-0) | March 28, 2024 |
| 50090-7218-0 | 50090-7218 | A-S Medication Solutions | 10 TABLET in 1 BOTTLE (50090-7218-0) | August 13, 2024 |
| 50090-7218-1 | 50090-7218 | A-S Medication Solutions | 15 TABLET in 1 BOTTLE (50090-7218-1) | August 13, 2024 |
| 50090-7218-2 | 50090-7218 | A-S Medication Solutions | 21 TABLET in 1 BOTTLE (50090-7218-2) | August 13, 2024 |
| 50090-7218-4 | 50090-7218 | A-S Medication Solutions | 50 TABLET in 1 BOTTLE (50090-7218-4) | August 13, 2024 |
| 50090-7218-5 | 50090-7218 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-7218-5) | August 13, 2024 |
| 50090-7218-7 | 50090-7218 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-7218-7) | August 13, 2024 |
| 50090-7218-8 | 50090-7218 | A-S Medication Solutions | 40 TABLET in 1 BOTTLE (50090-7218-8) | August 13, 2024 |
| 50090-7219-0 | 50090-7219 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-7219-0) | August 13, 2024 |
| 50090-7219-1 | 50090-7219 | A-S Medication Solutions | 20 TABLET in 1 BOTTLE (50090-7219-1) | August 13, 2024 |
| 50090-7235-0 | 50090-7235 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-7235-0) | August 26, 2024 |
| 50090-7369-0 | 50090-7369 | A-S Medication Solutions | 10 TABLET in 1 BOTTLE (50090-7369-0) | October 18, 2024 |
| 50090-7369-1 | 50090-7369 | A-S Medication Solutions | 15 TABLET in 1 BOTTLE (50090-7369-1) | October 18, 2024 |
| 50090-7369-2 | 50090-7369 | A-S Medication Solutions | 21 TABLET in 1 BOTTLE (50090-7369-2) | October 18, 2024 |
| 50090-7369-4 | 50090-7369 | A-S Medication Solutions | 50 TABLET in 1 BOTTLE (50090-7369-4) | October 18, 2024 |
| 50090-7369-5 | 50090-7369 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-7369-5) | October 18, 2024 |
| 50090-7369-7 | 50090-7369 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-7369-7) | October 18, 2024 |
| 50090-7369-8 | 50090-7369 | A-S Medication Solutions | 40 TABLET in 1 BOTTLE (50090-7369-8) | October 18, 2024 |
| 50090-7371-0 | 50090-7371 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-7371-0) | October 18, 2024 |
| 50090-7371-1 | 50090-7371 | A-S Medication Solutions | 20 TABLET in 1 BOTTLE (50090-7371-1) | October 18, 2024 |
| 50090-7441-0 | 50090-7441 | A-S Medication Solutions | 8 TABLET in 1 BOTTLE (50090-7441-0) | November 6, 2024 |
| 50090-7505-0 | 50090-7505 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7505-0) | February 17, 2025 |
| 50090-7684-0 | 50090-7684 | A-S Medication Solutions | 21 TABLET in 1 BOTTLE (50090-7684-0) | October 9, 2025 |
| 50090-7684-1 | 50090-7684 | A-S Medication Solutions | 50 TABLET in 1 BOTTLE (50090-7684-1) | October 9, 2025 |
| 50090-7684-3 | 50090-7684 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-7684-3) | October 9, 2025 |
| 50090-7684-4 | 50090-7684 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-7684-4) | October 9, 2025 |
| 50090-7684-7 | 50090-7684 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-7684-7) | October 9, 2025 |
| 50090-7686-6 | 50090-7686 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7686-6) | October 9, 2025 |
| 50090-7688-0 | 50090-7688 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7688-0) | October 9, 2025 |
| 50090-7825-0 | 50090-7825 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-7825-0) | December 16, 2025 |
| 50090-7931-0 | 50090-7931 | A-S Medication Solutions | 21 TABLET in 1 BOTTLE (50090-7931-0) | March 10, 2026 |
| 50090-7931-1 | 50090-7931 | A-S Medication Solutions | 50 TABLET in 1 BOTTLE (50090-7931-1) | March 10, 2026 |
| 50090-7931-3 | 50090-7931 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-7931-3) | March 10, 2026 |
| 50090-7931-4 | 50090-7931 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-7931-4) | March 10, 2026 |
| 50090-7931-7 | 50090-7931 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-7931-7) | March 10, 2026 |
| 50090-7933-0 | 50090-7933 | A-S Medication Solutions | 42 TABLET in 1 BOTTLE (50090-7933-0) | March 10, 2026 |
| 50090-7933-6 | 50090-7933 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7933-6) | March 24, 2026 |
| 50090-7935-0 | 50090-7935 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7935-0) | March 10, 2026 |
| 50090-8051-1 | 50090-8051 | A-S Medication Solutions | 10 TABLET in 1 BOTTLE (50090-8051-1) | September 14, 2026 |
| 50090-8051-2 | 50090-8051 | A-S Medication Solutions | 21 TABLET in 1 BOTTLE (50090-8051-2) | September 14, 2026 |
| 50090-8051-3 | 50090-8051 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-8051-3) | September 14, 2026 |
| 50090-8051-5 | 50090-8051 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-8051-5) | September 14, 2026 |
| 50090-8051-9 | 50090-8051 | A-S Medication Solutions | 18 TABLET in 1 BOTTLE (50090-8051-9) | September 14, 2026 |
| 50090-8052-0 | 50090-8052 | A-S Medication Solutions | 20 TABLET in 1 BOTTLE (50090-8052-0) | September 14, 2026 |
| 50090-8052-1 | 50090-8052 | A-S Medication Solutions | 12 TABLET in 1 BOTTLE (50090-8052-1) | September 14, 2026 |
| 50090-8052-2 | 50090-8052 | A-S Medication Solutions | 6 TABLET in 1 BOTTLE (50090-8052-2) | September 14, 2026 |
| 50090-8052-5 | 50090-8052 | A-S Medication Solutions | 14 TABLET in 1 BOTTLE (50090-8052-5) | September 14, 2026 |
| 50090-8052-7 | 50090-8052 | A-S Medication Solutions | 15 TABLET in 1 BOTTLE (50090-8052-7) | September 14, 2026 |
| 50090-8083-0 | 50090-8083 | A-S Medication Solutions | 8 TABLET in 1 BOTTLE (50090-8083-0) | September 21, 2026 |
| 50090-8083-2 | 50090-8083 | A-S Medication Solutions | 21 TABLET in 1 BOTTLE (50090-8083-2) | September 21, 2026 |
| 50090-8083-3 | 50090-8083 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-8083-3) | September 21, 2026 |
| 50090-8083-5 | 50090-8083 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-8083-5) | September 21, 2026 |
| 50090-8083-9 | 50090-8083 | A-S Medication Solutions | 18 TABLET in 1 BOTTLE (50090-8083-9) | September 21, 2026 |
| 50090-8084-0 | 50090-8084 | A-S Medication Solutions | 20 TABLET in 1 BOTTLE (50090-8084-0) | September 21, 2026 |
| 50090-8084-1 | 50090-8084 | A-S Medication Solutions | 12 TABLET in 1 BOTTLE (50090-8084-1) | September 21, 2026 |
| 50090-8084-2 | 50090-8084 | A-S Medication Solutions | 6 TABLET in 1 BOTTLE (50090-8084-2) | September 21, 2026 |
| 50090-8084-5 | 50090-8084 | A-S Medication Solutions | 14 TABLET in 1 BOTTLE (50090-8084-5) | September 21, 2026 |
| 50090-8084-7 | 50090-8084 | A-S Medication Solutions | 15 TABLET in 1 BOTTLE (50090-8084-7) | September 21, 2026 |
| 50090-8087-0 | 50090-8087 | A-S Medication Solutions | 21 TABLET in 1 BOTTLE (50090-8087-0) | September 21, 2026 |
| 70954-056-10 | 70954-056 | ANI Pharmaceuticals, Inc. | 100 TABLET in 1 BOTTLE (70954-056-10) | July 6, 2021 |
| 70954-056-20 | 70954-056 | ANI Pharmaceuticals, Inc. | 1000 TABLET in 1 BOTTLE (70954-056-20) | July 6, 2021 |
| 70954-057-10 | 70954-057 | ANI Pharmaceuticals, Inc. | 100 TABLET in 1 BOTTLE (70954-057-10) | November 15, 2019 |
| 70954-058-10 | 70954-058 | ANI Pharmaceuticals, Inc. | 100 TABLET in 1 BOTTLE (70954-058-10) | November 15, 2019 |
| 70954-058-20 | 70954-058 | ANI Pharmaceuticals, Inc. | 1000 TABLET in 1 BOTTLE (70954-058-20) | November 15, 2019 |
| 70954-058-30 | 70954-058 | ANI Pharmaceuticals, Inc. | 1 BLISTER PACK in 1 BOX (70954-058-30) / 21 TABLET in 1 BLISTER PACK | May 28, 2020 |
| 70954-058-40 | 70954-058 | ANI Pharmaceuticals, Inc. | 1 BLISTER PACK in 1 BOX (70954-058-40) / 48 TABLET in 1 BLISTER PACK | May 28, 2020 |
| 70954-059-10 | 70954-059 | ANI Pharmaceuticals, Inc. | 100 TABLET in 1 BOTTLE (70954-059-10) | November 15, 2019 |
| 70954-059-20 | 70954-059 | ANI Pharmaceuticals, Inc. | 1000 TABLET in 1 BOTTLE (70954-059-20) | November 15, 2019 |
| 70954-059-30 | 70954-059 | ANI Pharmaceuticals, Inc. | 1 BLISTER PACK in 1 BOX (70954-059-30) / 21 TABLET in 1 BLISTER PACK | May 28, 2020 |
| 70954-059-40 | 70954-059 | ANI Pharmaceuticals, Inc. | 1 BLISTER PACK in 1 BOX (70954-059-40) / 48 TABLET in 1 BLISTER PACK | May 28, 2020 |
| 70954-060-10 | 70954-060 | ANI Pharmaceuticals, Inc. | 100 TABLET in 1 BOTTLE (70954-060-10) | November 15, 2019 |
| 70954-060-20 | 70954-060 | ANI Pharmaceuticals, Inc. | 500 TABLET in 1 BOTTLE (70954-060-20) | November 15, 2019 |
| 70954-060-30 | 70954-060 | ANI Pharmaceuticals, Inc. | 1000 TABLET in 1 BOTTLE (70954-060-30) | November 15, 2019 |
| 70954-061-10 | 70954-061 | ANI Pharmaceuticals, Inc. | 100 TABLET in 1 BOTTLE (70954-061-10) | November 15, 2019 |
| 87063-042-01 | 87063-042 | ASCLEMED USA INC. | 100 TABLET in 1 BOTTLE (87063-042-01) | December 3, 2025 |
| 87063-042-18 | 87063-042 | ASCLEMED USA INC. | 18 TABLET in 1 BOTTLE (87063-042-18) | December 3, 2025 |
| 87063-042-20 | 87063-042 | ASCLEMED USA INC. | 20 TABLET in 1 BOTTLE (87063-042-20) | December 3, 2025 |
| 87063-042-21 | 87063-042 | ASCLEMED USA INC. | 21 TABLET in 1 BOTTLE (87063-042-21) | December 3, 2025 |
| 87063-042-30 | 87063-042 | ASCLEMED USA INC. | 30 TABLET in 1 BOTTLE (87063-042-30) | December 3, 2025 |
| 87063-042-60 | 87063-042 | ASCLEMED USA INC. | 60 TABLET in 1 BOTTLE (87063-042-60) | December 3, 2025 |
| 87063-042-78 | 87063-042 | ASCLEMED USA INC. | 10 BLISTER PACK in 1 CARTON (87063-042-78) / 10 TABLET in 1 BLISTER PACK | December 3, 2025 |
| 87063-042-90 | 87063-042 | ASCLEMED USA INC. | 90 TABLET in 1 BOTTLE (87063-042-90) | December 3, 2025 |
| 87063-043-01 | 87063-043 | ASCLEMED USA INC. | 100 TABLET in 1 BOTTLE (87063-043-01) | December 3, 2025 |
| 87063-043-18 | 87063-043 | ASCLEMED USA INC. | 18 TABLET in 1 BOTTLE (87063-043-18) | December 3, 2025 |
| 87063-043-20 | 87063-043 | ASCLEMED USA INC. | 20 TABLET in 1 BOTTLE (87063-043-20) | December 3, 2025 |
| 87063-043-21 | 87063-043 | ASCLEMED USA INC. | 21 TABLET in 1 BOTTLE (87063-043-21) | December 3, 2025 |
| 87063-043-30 | 87063-043 | ASCLEMED USA INC. | 30 TABLET in 1 BOTTLE (87063-043-30) | December 3, 2025 |
| 87063-043-60 | 87063-043 | ASCLEMED USA INC. | 60 TABLET in 1 BOTTLE (87063-043-60) | December 3, 2025 |
| 87063-043-78 | 87063-043 | ASCLEMED USA INC. | 10 BLISTER PACK in 1 CARTON (87063-043-78) / 10 TABLET in 1 BLISTER PACK | December 3, 2025 |
| 87063-043-90 | 87063-043 | ASCLEMED USA INC. | 90 TABLET in 1 BOTTLE (87063-043-90) | December 3, 2025 |
| 87063-044-01 | 87063-044 | ASCLEMED USA INC. | 100 TABLET in 1 BOTTLE (87063-044-01) | December 3, 2025 |
| 87063-044-18 | 87063-044 | ASCLEMED USA INC. | 18 TABLET in 1 BOTTLE (87063-044-18) | December 3, 2025 |
| 87063-044-20 | 87063-044 | ASCLEMED USA INC. | 20 TABLET in 1 BOTTLE (87063-044-20) | December 3, 2025 |
| 87063-044-21 | 87063-044 | ASCLEMED USA INC. | 21 TABLET in 1 BOTTLE (87063-044-21) | December 3, 2025 |
| 87063-044-30 | 87063-044 | ASCLEMED USA INC. | 30 TABLET in 1 BOTTLE (87063-044-30) | December 3, 2025 |
| 87063-044-60 | 87063-044 | ASCLEMED USA INC. | 60 TABLET in 1 BOTTLE (87063-044-60) | December 3, 2025 |
| 87063-044-78 | 87063-044 | ASCLEMED USA INC. | 10 BLISTER PACK in 1 CARTON (87063-044-78) / 10 TABLET in 1 BLISTER PACK | December 3, 2025 |
| 87063-044-90 | 87063-044 | ASCLEMED USA INC. | 90 TABLET in 1 BOTTLE (87063-044-90) | December 3, 2025 |
| 87063-045-01 | 87063-045 | ASCLEMED USA INC. | 100 TABLET in 1 BOTTLE (87063-045-01) | December 3, 2025 |
| 87063-045-18 | 87063-045 | ASCLEMED USA INC. | 18 TABLET in 1 BOTTLE (87063-045-18) | December 3, 2025 |
| 87063-045-20 | 87063-045 | ASCLEMED USA INC. | 20 TABLET in 1 BOTTLE (87063-045-20) | December 3, 2025 |
| 87063-045-21 | 87063-045 | ASCLEMED USA INC. | 21 TABLET in 1 BOTTLE (87063-045-21) | December 3, 2025 |
| 87063-045-30 | 87063-045 | ASCLEMED USA INC. | 30 TABLET in 1 BOTTLE (87063-045-30) | December 3, 2025 |
| 87063-045-60 | 87063-045 | ASCLEMED USA INC. | 60 TABLET in 1 BOTTLE (87063-045-60) | December 3, 2025 |
| 87063-045-78 | 87063-045 | ASCLEMED USA INC. | 10 BLISTER PACK in 1 CARTON (87063-045-78) / 10 TABLET in 1 BLISTER PACK | December 3, 2025 |
| 87063-045-90 | 87063-045 | ASCLEMED USA INC. | 90 TABLET in 1 BOTTLE (87063-045-90) | December 3, 2025 |
| 87063-048-01 | 87063-048 | ASCLEMED USA INC. | 100 TABLET in 1 BOTTLE (87063-048-01) | December 3, 2025 |
| 87063-048-18 | 87063-048 | ASCLEMED USA INC. | 18 TABLET in 1 BOTTLE (87063-048-18) | December 3, 2025 |
| 87063-048-20 | 87063-048 | ASCLEMED USA INC. | 20 TABLET in 1 BOTTLE (87063-048-20) | December 3, 2025 |
| 87063-048-21 | 87063-048 | ASCLEMED USA INC. | 21 TABLET in 1 BOTTLE (87063-048-21) | December 3, 2025 |
| 87063-048-30 | 87063-048 | ASCLEMED USA INC. | 30 TABLET in 1 BOTTLE (87063-048-30) | December 3, 2025 |
| 87063-048-60 | 87063-048 | ASCLEMED USA INC. | 60 TABLET in 1 BOTTLE (87063-048-60) | December 3, 2025 |
| 87063-048-78 | 87063-048 | ASCLEMED USA INC. | 10 BLISTER PACK in 1 CARTON (87063-048-78) / 10 TABLET in 1 BLISTER PACK | December 3, 2025 |
| 87063-048-90 | 87063-048 | ASCLEMED USA INC. | 90 TABLET in 1 BOTTLE (87063-048-90) | December 3, 2025 |
| 0591-5052-00 | 0591-5052 | Actavis Pharma, Inc. | 111000 TABLET in 1 BAG (0591-5052-00) | November 1, 1987 |
| 0591-5052-01 | 0591-5052 | Actavis Pharma, Inc. | 100 TABLET in 1 BOTTLE (0591-5052-01) | January 1, 1990 |
| 0591-5052-10 | 0591-5052 | Actavis Pharma, Inc. | 1000 TABLET in 1 BOTTLE (0591-5052-10) | January 1, 1990 |
| 0591-5052-21 | 0591-5052 | Actavis Pharma, Inc. | 1 BLISTER PACK in 1 CARTON (0591-5052-21) / 21 TABLET in 1 BLISTER PACK | May 25, 2016 |
| 0591-5052-43 | 0591-5052 | Actavis Pharma, Inc. | 1 BLISTER PACK in 1 CARTON (0591-5052-43) / 48 TABLET in 1 BLISTER PACK | May 25, 2016 |
| 0591-5052-77 | 0591-5052 | Actavis Pharma, Inc. | 133332 TABLET in 1 CONTAINER (0591-5052-77) | June 30, 2024 |
| 0591-5442-00 | 0591-5442 | Actavis Pharma, Inc. | 47000 TABLET in 1 BAG (0591-5442-00) | November 1, 1987 |
| 0591-5442-01 | 0591-5442 | Actavis Pharma, Inc. | 100 TABLET in 1 BOTTLE (0591-5442-01) | January 1, 1990 |
| 0591-5442-05 | 0591-5442 | Actavis Pharma, Inc. | 500 TABLET in 1 BOTTLE (0591-5442-05) | January 1, 1990 |
| 0591-5442-10 | 0591-5442 | Actavis Pharma, Inc. | 1000 TABLET in 1 BOTTLE (0591-5442-10) | May 18, 1993 |
| 0591-5442-21 | 0591-5442 | Actavis Pharma, Inc. | 1 BLISTER PACK in 1 CARTON (0591-5442-21) / 21 TABLET in 1 BLISTER PACK | May 25, 2016 |
| 0591-5442-43 | 0591-5442 | Actavis Pharma, Inc. | 1 BLISTER PACK in 1 CARTON (0591-5442-43) / 48 TABLET in 1 BLISTER PACK | May 25, 2016 |
| 0591-5442-77 | 0591-5442 | Actavis Pharma, Inc. | 56604 TABLET in 1 CONTAINER (0591-5442-77) | June 30, 2024 |
| 0591-5443-00 | 0591-5443 | Actavis Pharma, Inc. | 31000 TABLET in 1 BAG (0591-5443-00) | November 1, 1987 |
| 0591-5443-01 | 0591-5443 | Actavis Pharma, Inc. | 100 TABLET in 1 BOTTLE (0591-5443-01) | January 1, 1990 |
| 0591-5443-05 | 0591-5443 | Actavis Pharma, Inc. | 500 TABLET in 1 BOTTLE (0591-5443-05) | January 1, 1990 |
| 0591-5443-10 | 0591-5443 | Actavis Pharma, Inc. | 1000 TABLET in 1 BOTTLE (0591-5443-10) | November 11, 1993 |
| 0591-5443-77 | 0591-5443 | Actavis Pharma, Inc. | 36912 TABLET in 1 CONTAINER (0591-5443-77) | June 30, 2024 |
| 80425-0105-1 | 80425-0105 | Advanced Rx Pharmacy of Tennessee, LLC | 20 TABLET in 1 BOTTLE (80425-0105-1) | August 29, 2001 |
| 80425-0105-2 | 80425-0105 | Advanced Rx Pharmacy of Tennessee, LLC | 10 TABLET in 1 BOTTLE (80425-0105-2) | March 30, 2023 |
| 80425-0105-3 | 80425-0105 | Advanced Rx Pharmacy of Tennessee, LLC | 15 TABLET in 1 BOTTLE (80425-0105-3) | May 16, 2023 |
| 80425-0106-1 | 80425-0106 | Advanced Rx Pharmacy of Tennessee, LLC | 21 TABLET in 1 BOTTLE (80425-0106-1) | August 29, 2001 |
| 80425-0193-1 | 80425-0193 | Advanced Rx Pharmacy of Tennessee, LLC | 21 TABLET in 1 BOTTLE (80425-0193-1) | June 20, 2024 |
| 80425-0068-1 | 80425-0068 | Advanced Rx of Tennessee, LLC | 21 TABLET in 1 BOTTLE (80425-0068-1) | September 15, 2022 |
| 80425-0069-1 | 80425-0069 | Advanced Rx of Tennessee, LLC | 21 TABLET in 1 BOTTLE (80425-0069-1) | August 29, 2001 |
| 80425-0479-1 | 80425-0479 | Advanced Rx of Tennessee, LLC | 21 TABLET in 1 BOTTLE (80425-0479-1) | March 28, 2022 |
| 80425-0480-1 | 80425-0480 | Advanced Rx of Tennessee, LLC | 21 TABLET in 1 BOTTLE (80425-0480-1) | February 14, 2025 |
| 80425-0481-1 | 80425-0481 | Advanced Rx of Tennessee, LLC | 21 TABLET in 1 BOTTLE (80425-0481-1) | February 14, 2025 |
| 80425-0482-1 | 80425-0482 | Advanced Rx of Tennessee, LLC | 21 TABLET in 1 BOTTLE, PLASTIC (80425-0482-1) | February 17, 2025 |
| 80425-0484-1 | 80425-0484 | Advanced Rx of Tennessee, LLC | 21 TABLET in 1 BOTTLE, PLASTIC (80425-0484-1) | January 31, 2025 |
| 80425-0485-1 | 80425-0485 | Advanced Rx of Tennessee, LLC | 21 TABLET in 1 BOTTLE (80425-0485-1) | February 14, 2025 |
| 80425-0486-1 | 80425-0486 | Advanced Rx of Tennessee, LLC | 21 TABLET in 1 BOTTLE (80425-0486-1) | March 17, 2025 |
| 80425-0486-2 | 80425-0486 | Advanced Rx of Tennessee, LLC | 14 TABLET in 1 BOTTLE (80425-0486-2) | March 17, 2025 |
| 80425-0486-3 | 80425-0486 | Advanced Rx of Tennessee, LLC | 10 TABLET in 1 BOTTLE (80425-0486-3) | April 4, 2025 |
| 80425-0486-4 | 80425-0486 | Advanced Rx of Tennessee, LLC | 15 TABLET in 1 BOTTLE (80425-0486-4) | April 4, 2025 |
| 80425-0486-5 | 80425-0486 | Advanced Rx of Tennessee, LLC | 20 TABLET in 1 BOTTLE (80425-0486-5) | April 4, 2025 |
| 80425-0487-1 | 80425-0487 | Advanced Rx of Tennessee, LLC | 21 TABLET in 1 BOTTLE, PLASTIC (80425-0487-1) | January 31, 2025 |
| 80425-0487-2 | 80425-0487 | Advanced Rx of Tennessee, LLC | 14 TABLET in 1 BOTTLE, PLASTIC (80425-0487-2) | April 4, 2025 |
| 80425-0487-3 | 80425-0487 | Advanced Rx of Tennessee, LLC | 10 TABLET in 1 BOTTLE, PLASTIC (80425-0487-3) | April 4, 2025 |
| 80425-0487-4 | 80425-0487 | Advanced Rx of Tennessee, LLC | 15 TABLET in 1 BOTTLE, PLASTIC (80425-0487-4) | April 4, 2025 |
| 80425-0487-5 | 80425-0487 | Advanced Rx of Tennessee, LLC | 20 TABLET in 1 BOTTLE, PLASTIC (80425-0487-5) | April 4, 2025 |
| 80425-0491-1 | 80425-0491 | Advanced Rx of Tennessee, LLC | 1 BLISTER PACK in 1 CARTON (80425-0491-1) / 21 TABLET in 1 BLISTER PACK | March 17, 2025 |
| 60687-122-01 | 60687-122 | American Health Packaging | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-122-01) / 1 TABLET in 1 BLISTER PACK (60687-122-11) | September 10, 2015 |
| 60687-134-01 | 60687-134 | American Health Packaging | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-134-01) / 1 TABLET in 1 BLISTER PACK (60687-134-11) | September 14, 2015 |
| 60687-145-01 | 60687-145 | American Health Packaging | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-145-01) / 1 TABLET in 1 BLISTER PACK (60687-145-11) | October 5, 2015 |
| 60687-854-01 | 60687-854 | American Health Packaging | 100 BLISTER PACK in 1 CARTON (60687-854-01) / 1 TABLET in 1 BLISTER PACK (60687-854-11) | November 19, 2024 |
| 60687-903-01 | 60687-903 | American Health Packaging | 100 BLISTER PACK in 1 CARTON (60687-903-01) / 1 TABLET in 1 BLISTER PACK (60687-903-11) | January 9, 2026 |
| 60687-914-01 | 60687-914 | American Health Packaging | 100 BLISTER PACK in 1 CARTON (60687-914-01) / 1 TABLET in 1 BLISTER PACK (60687-914-11) | December 23, 2025 |
| 60687-925-01 | 60687-925 | American Health Packaging | 100 BLISTER PACK in 1 CARTON (60687-925-01) / 1 TABLET in 1 BLISTER PACK (60687-925-11) | December 29, 2025 |
| 60219-1705-1 | 60219-1705 | Amneal Pharmaceuticals NY LLC | 100 TABLET in 1 BOTTLE, PLASTIC (60219-1705-1) | August 4, 2021 |
| 60219-1706-1 | 60219-1706 | Amneal Pharmaceuticals NY LLC | 100 TABLET in 1 BOTTLE, PLASTIC (60219-1706-1) | August 4, 2021 |
| 60219-1706-3 | 60219-1706 | Amneal Pharmaceuticals NY LLC | 10 BLISTER PACK in 1 CARTON (60219-1706-3) / 10 TABLET in 1 BLISTER PACK (60219-1706-2) | August 4, 2021 |
| 60219-1706-7 | 60219-1706 | Amneal Pharmaceuticals NY LLC | 1000 TABLET in 1 BOTTLE, PLASTIC (60219-1706-7) | August 4, 2021 |
| 60219-1707-1 | 60219-1707 | Amneal Pharmaceuticals NY LLC | 100 TABLET in 1 BOTTLE, PLASTIC (60219-1707-1) | June 24, 2020 |
| 60219-1707-3 | 60219-1707 | Amneal Pharmaceuticals NY LLC | 10 BLISTER PACK in 1 CARTON (60219-1707-3) / 10 TABLET in 1 BLISTER PACK (60219-1707-2) | June 24, 2020 |
| 60219-1707-5 | 60219-1707 | Amneal Pharmaceuticals NY LLC | 500 TABLET in 1 BOTTLE, PLASTIC (60219-1707-5) | June 24, 2020 |
| 60219-1708-1 | 60219-1708 | Amneal Pharmaceuticals NY LLC | 100 TABLET in 1 BOTTLE, PLASTIC (60219-1708-1) | June 24, 2020 |
| 60219-1708-5 | 60219-1708 | Amneal Pharmaceuticals NY LLC | 500 TABLET in 1 BOTTLE, PLASTIC (60219-1708-5) | June 24, 2020 |
| 67544-399-60 | 67544-399 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE, PLASTIC (67544-399-60) | December 21, 2017 |
| 71610-834-30 | 71610-834 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET in 1 BOTTLE (71610-834-30) | May 13, 2024 |
| 71610-834-53 | 71610-834 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE (71610-834-53) | May 13, 2024 |
| 71610-834-60 | 71610-834 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-834-60) | May 13, 2024 |
| 71610-834-80 | 71610-834 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (71610-834-80) | July 18, 2024 |
| 76420-067-21 | 76420-067 | Asclemed USA, Inc. | 21 TABLET in 1 BOTTLE (76420-067-21) | August 28, 2020 |
| 76420-067-30 | 76420-067 | Asclemed USA, Inc. | 30 TABLET in 1 BOTTLE (76420-067-30) | August 28, 2020 |
| 76420-067-48 | 76420-067 | Asclemed USA, Inc. | 48 TABLET in 1 BOTTLE (76420-067-48) | August 28, 2020 |
| 76420-068-20 | 76420-068 | Asclemed USA, Inc. | 20 TABLET in 1 BOTTLE (76420-068-20) | August 28, 2020 |
| 76420-068-21 | 76420-068 | Asclemed USA, Inc. | 21 TABLET in 1 BOTTLE (76420-068-21) | August 28, 2020 |
| 76420-068-30 | 76420-068 | Asclemed USA, Inc. | 30 TABLET in 1 BOTTLE (76420-068-30) | August 28, 2020 |
| 76420-068-40 | 76420-068 | Asclemed USA, Inc. | 40 TABLET in 1 BOTTLE (76420-068-40) | August 28, 2020 |
| 76420-068-60 | 76420-068 | Asclemed USA, Inc. | 60 TABLET in 1 BOTTLE (76420-068-60) | August 28, 2020 |
| 76420-069-10 | 76420-069 | Asclemed USA, Inc. | 10 TABLET in 1 BOTTLE (76420-069-10) | August 28, 2020 |
| 76420-069-15 | 76420-069 | Asclemed USA, Inc. | 15 TABLET in 1 BOTTLE (76420-069-15) | August 28, 2020 |
| 76420-069-20 | 76420-069 | Asclemed USA, Inc. | 20 TABLET in 1 BOTTLE (76420-069-20) | August 28, 2020 |
| 76420-069-21 | 76420-069 | Asclemed USA, Inc. | 21 TABLET in 1 BOTTLE (76420-069-21) | August 28, 2020 |
| 76420-069-30 | 76420-069 | Asclemed USA, Inc. | 30 TABLET in 1 BOTTLE (76420-069-30) | August 28, 2020 |
| 76420-412-00 | 76420-412 | Asclemed USA, Inc. | 1000 TABLET in 1 BOTTLE, PLASTIC (76420-412-00) | July 9, 2025 |
| 76420-412-01 | 76420-412 | Asclemed USA, Inc. | 100 TABLET in 1 BOTTLE, PLASTIC (76420-412-01) | July 9, 2025 |
| 76420-412-05 | 76420-412 | Asclemed USA, Inc. | 5 TABLET in 1 BOTTLE, PLASTIC (76420-412-05) | July 9, 2025 |
| 76420-412-10 | 76420-412 | Asclemed USA, Inc. | 10 TABLET in 1 BOTTLE, PLASTIC (76420-412-10) | January 24, 2026 |
| 76420-412-18 | 76420-412 | Asclemed USA, Inc. | 18 TABLET in 1 BOTTLE, PLASTIC (76420-412-18) | July 9, 2025 |
| 76420-412-20 | 76420-412 | Asclemed USA, Inc. | 20 TABLET in 1 BOTTLE, PLASTIC (76420-412-20) | July 9, 2025 |
| 76420-412-21 | 76420-412 | Asclemed USA, Inc. | 21 TABLET in 1 BOTTLE, PLASTIC (76420-412-21) | January 28, 2026 |
| 76420-412-30 | 76420-412 | Asclemed USA, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (76420-412-30) | July 9, 2025 |
| 76420-412-50 | 76420-412 | Asclemed USA, Inc. | 500 TABLET in 1 BOTTLE, PLASTIC (76420-412-50) | July 9, 2025 |
| 76420-412-60 | 76420-412 | Asclemed USA, Inc. | 60 TABLET in 1 BOTTLE, PLASTIC (76420-412-60) | July 9, 2025 |
| 76420-412-90 | 76420-412 | Asclemed USA, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (76420-412-90) | July 9, 2025 |
| 76420-413-00 | 76420-413 | Asclemed USA, Inc. | 1000 TABLET in 1 BOTTLE, PLASTIC (76420-413-00) | July 9, 2025 |
| 76420-413-01 | 76420-413 | Asclemed USA, Inc. | 100 TABLET in 1 BOTTLE, PLASTIC (76420-413-01) | July 9, 2025 |
| 76420-413-05 | 76420-413 | Asclemed USA, Inc. | 5 TABLET in 1 BOTTLE, PLASTIC (76420-413-05) | July 9, 2025 |
| 76420-413-10 | 76420-413 | Asclemed USA, Inc. | 10 TABLET in 1 BOTTLE, PLASTIC (76420-413-10) | January 24, 2026 |
| 76420-413-18 | 76420-413 | Asclemed USA, Inc. | 18 TABLET in 1 BOTTLE, PLASTIC (76420-413-18) | July 9, 2025 |
| 76420-413-20 | 76420-413 | Asclemed USA, Inc. | 20 TABLET in 1 BOTTLE, PLASTIC (76420-413-20) | July 9, 2025 |
| 76420-413-21 | 76420-413 | Asclemed USA, Inc. | 21 TABLET in 1 BOTTLE, PLASTIC (76420-413-21) | January 28, 2026 |
| 76420-413-30 | 76420-413 | Asclemed USA, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (76420-413-30) | July 9, 2025 |
| 76420-413-50 | 76420-413 | Asclemed USA, Inc. | 500 TABLET in 1 BOTTLE, PLASTIC (76420-413-50) | July 9, 2025 |
| 76420-413-60 | 76420-413 | Asclemed USA, Inc. | 60 TABLET in 1 BOTTLE, PLASTIC (76420-413-60) | July 9, 2025 |
| 76420-413-90 | 76420-413 | Asclemed USA, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (76420-413-90) | July 9, 2025 |
| 76420-414-01 | 76420-414 | Asclemed USA, Inc. | 100 TABLET in 1 BOTTLE (76420-414-01) | July 9, 2025 |
| 76420-414-05 | 76420-414 | Asclemed USA, Inc. | 5 TABLET in 1 BOTTLE (76420-414-05) | July 9, 2025 |
| 76420-414-10 | 76420-414 | Asclemed USA, Inc. | 10 TABLET in 1 BOTTLE (76420-414-10) | January 24, 2026 |
| 76420-414-18 | 76420-414 | Asclemed USA, Inc. | 18 TABLET in 1 BOTTLE (76420-414-18) | July 9, 2025 |
| 76420-414-20 | 76420-414 | Asclemed USA, Inc. | 20 TABLET in 1 BOTTLE (76420-414-20) | July 9, 2025 |
| 76420-414-21 | 76420-414 | Asclemed USA, Inc. | 21 TABLET in 1 BOTTLE (76420-414-21) | January 28, 2026 |
| 76420-414-30 | 76420-414 | Asclemed USA, Inc. | 30 TABLET in 1 BOTTLE (76420-414-30) | July 9, 2025 |
| 76420-414-60 | 76420-414 | Asclemed USA, Inc. | 60 TABLET in 1 BOTTLE (76420-414-60) | July 9, 2025 |
| 76420-414-90 | 76420-414 | Asclemed USA, Inc. | 90 TABLET in 1 BOTTLE (76420-414-90) | July 9, 2025 |
| 59651-484-01 | 59651-484 | Aurobindo Pharma Limited | 100 TABLET in 1 BOTTLE (59651-484-01) | November 16, 2021 |
| 59651-484-78 | 59651-484 | Aurobindo Pharma Limited | 10 BLISTER PACK in 1 CARTON (59651-484-78) / 10 TABLET in 1 BLISTER PACK | November 16, 2021 |
| 59651-484-99 | 59651-484 | Aurobindo Pharma Limited | 1000 TABLET in 1 BOTTLE (59651-484-99) | November 16, 2021 |
| 59651-485-01 | 59651-485 | Aurobindo Pharma Limited | 100 TABLET in 1 BOTTLE (59651-485-01) | March 28, 2022 |
| 59651-485-78 | 59651-485 | Aurobindo Pharma Limited | 10 BLISTER PACK in 1 CARTON (59651-485-78) / 10 TABLET in 1 BLISTER PACK | March 28, 2022 |
| 59651-486-01 | 59651-486 | Aurobindo Pharma Limited | 100 TABLET in 1 BOTTLE (59651-486-01) | March 28, 2022 |
| 59651-486-78 | 59651-486 | Aurobindo Pharma Limited | 10 BLISTER PACK in 1 CARTON (59651-486-78) / 10 TABLET in 1 BLISTER PACK | March 28, 2022 |
| 59651-486-99 | 59651-486 | Aurobindo Pharma Limited | 1000 TABLET in 1 BOTTLE (59651-486-99) | March 28, 2022 |
| 59651-487-01 | 59651-487 | Aurobindo Pharma Limited | 100 TABLET in 1 BOTTLE (59651-487-01) | March 28, 2022 |
| 59651-487-05 | 59651-487 | Aurobindo Pharma Limited | 500 TABLET in 1 BOTTLE (59651-487-05) | March 28, 2022 |
| 59651-487-78 | 59651-487 | Aurobindo Pharma Limited | 10 BLISTER PACK in 1 CARTON (59651-487-78) / 10 TABLET in 1 BLISTER PACK | March 28, 2022 |
| 59651-488-01 | 59651-488 | Aurobindo Pharma Limited | 100 TABLET in 1 BOTTLE (59651-488-01) | March 28, 2022 |
| 59651-488-05 | 59651-488 | Aurobindo Pharma Limited | 500 TABLET in 1 BOTTLE (59651-488-05) | March 28, 2022 |
| 59651-488-78 | 59651-488 | Aurobindo Pharma Limited | 10 BLISTER PACK in 1 CARTON (59651-488-78) / 10 TABLET in 1 BLISTER PACK | March 28, 2022 |
| 59651-489-01 | 59651-489 | Aurobindo Pharma Limited | 100 TABLET in 1 BOTTLE (59651-489-01) | March 28, 2022 |
| 59651-489-78 | 59651-489 | Aurobindo Pharma Limited | 10 BLISTER PACK in 1 CARTON (59651-489-78) / 10 TABLET in 1 BLISTER PACK | March 28, 2022 |
| 63629-1605-0 | 63629-1605 | Bryant Ranch Prepack | 42 TABLET in 1 BOTTLE (63629-1605-0) | June 8, 2010 |
| 63629-1605-1 | 63629-1605 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (63629-1605-1) | December 7, 2004 |
| 63629-1605-2 | 63629-1605 | Bryant Ranch Prepack | 78 TABLET in 1 BOTTLE (63629-1605-2) | March 18, 2005 |
| 63629-1605-3 | 63629-1605 | Bryant Ranch Prepack | 36 TABLET in 1 BOTTLE (63629-1605-3) | March 12, 2010 |
| 63629-1605-4 | 63629-1605 | Bryant Ranch Prepack | 21 TABLET in 1 BOTTLE (63629-1605-4) | January 10, 2005 |
| 63629-1605-5 | 63629-1605 | Bryant Ranch Prepack | 15 TABLET in 1 BOTTLE (63629-1605-5) | February 11, 2005 |
| 63629-1605-6 | 63629-1605 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (63629-1605-6) | September 15, 2008 |
| 63629-1605-7 | 63629-1605 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (63629-1605-7) | June 15, 2009 |
| 63629-1605-8 | 63629-1605 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (63629-1605-8) | January 18, 2010 |
| 63629-1605-9 | 63629-1605 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (63629-1605-9) | April 20, 2010 |
| 63629-2254-1 | 63629-2254 | Bryant Ranch Prepack | 1000 TABLET in 1 BOTTLE, PLASTIC (63629-2254-1) | December 21, 2004 |
| 63629-2257-1 | 63629-2257 | Bryant Ranch Prepack | 1000 TABLET in 1 BOTTLE, PLASTIC (63629-2257-1) | July 12, 2002 |
| 63629-2260-1 | 63629-2260 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE, PLASTIC (63629-2260-1) | October 9, 2024 |
| 63629-2264-1 | 63629-2264 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE, PLASTIC (63629-2264-1) | July 12, 2002 |
| 71335-1780-0 | 71335-1780 | Bryant Ranch Prepack | 42 TABLET in 1 BOTTLE (71335-1780-0) | July 13, 2021 |
| 71335-1780-1 | 71335-1780 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1780-1) | April 26, 2021 |
| 71335-1780-2 | 71335-1780 | Bryant Ranch Prepack | 78 TABLET in 1 BOTTLE (71335-1780-2) | August 20, 2026 |
| 71335-1780-3 | 71335-1780 | Bryant Ranch Prepack | 36 TABLET in 1 BOTTLE (71335-1780-3) | August 20, 2026 |
| 71335-1780-4 | 71335-1780 | Bryant Ranch Prepack | 21 TABLET in 1 BOTTLE (71335-1780-4) | February 26, 2021 |
| 71335-1780-5 | 71335-1780 | Bryant Ranch Prepack | 15 TABLET in 1 BOTTLE (71335-1780-5) | May 3, 2021 |
| 71335-1780-6 | 71335-1780 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-1780-6) | May 25, 2021 |
| 71335-1780-7 | 71335-1780 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (71335-1780-7) | August 20, 2026 |
| 71335-1780-8 | 71335-1780 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (71335-1780-8) | June 15, 2021 |
| 71335-1780-9 | 71335-1780 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-1780-9) | August 20, 2026 |
| 71335-2069-0 | 71335-2069 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (71335-2069-0) | May 2, 2022 |
| 71335-2069-1 | 71335-2069 | Bryant Ranch Prepack | 21 TABLET in 1 BOTTLE (71335-2069-1) | April 11, 2022 |
| 71335-2069-2 | 71335-2069 | Bryant Ranch Prepack | 40 TABLET in 1 BOTTLE (71335-2069-2) | April 19, 2022 |
| 71335-2069-3 | 71335-2069 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-2069-3) | March 30, 2022 |
| 71335-2069-4 | 71335-2069 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (71335-2069-4) | April 29, 2022 |
| 71335-2069-5 | 71335-2069 | Bryant Ranch Prepack | 15 TABLET in 1 BOTTLE (71335-2069-5) | July 5, 2022 |
| 71335-2069-6 | 71335-2069 | Bryant Ranch Prepack | 50 TABLET in 1 BOTTLE (71335-2069-6) | April 3, 2024 |
| 71335-2069-7 | 71335-2069 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-2069-7) | June 1, 2022 |
| 71335-2069-8 | 71335-2069 | Bryant Ranch Prepack | 42 TABLET in 1 BOTTLE (71335-2069-8) | May 31, 2022 |
| 71335-2069-9 | 71335-2069 | Bryant Ranch Prepack | 48 TABLET in 1 BOTTLE (71335-2069-9) | April 3, 2024 |
| 71335-2079-0 | 71335-2079 | Bryant Ranch Prepack | 11 TABLET in 1 BOTTLE, PLASTIC (71335-2079-0) | May 3, 2022 |
| 71335-2079-1 | 71335-2079 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE, PLASTIC (71335-2079-1) | May 6, 2022 |
| 71335-2079-2 | 71335-2079 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE, PLASTIC (71335-2079-2) | May 31, 2022 |
| 71335-2079-3 | 71335-2079 | Bryant Ranch Prepack | 40 TABLET in 1 BOTTLE, PLASTIC (71335-2079-3) | September 6, 2022 |
| 71335-2079-4 | 71335-2079 | Bryant Ranch Prepack | 15 TABLET in 1 BOTTLE, PLASTIC (71335-2079-4) | June 9, 2022 |
| 71335-2079-5 | 71335-2079 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE, PLASTIC (71335-2079-5) | April 27, 2022 |
| 71335-2079-6 | 71335-2079 | Bryant Ranch Prepack | 21 TABLET in 1 BOTTLE, PLASTIC (71335-2079-6) | June 2, 2022 |
| 71335-2079-7 | 71335-2079 | Bryant Ranch Prepack | 18 TABLET in 1 BOTTLE, PLASTIC (71335-2079-7) | June 23, 2022 |
| 71335-2079-8 | 71335-2079 | Bryant Ranch Prepack | 12 TABLET in 1 BOTTLE, PLASTIC (71335-2079-8) | April 18, 2022 |
| 71335-2079-9 | 71335-2079 | Bryant Ranch Prepack | 23 TABLET in 1 BOTTLE, PLASTIC (71335-2079-9) | April 3, 2024 |
| 71335-2088-1 | 71335-2088 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-2088-1) | April 14, 2023 |
| 71335-2088-2 | 71335-2088 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-2088-2) | May 6, 2022 |
| 71335-2122-0 | 71335-2122 | Bryant Ranch Prepack | 12 TABLET in 1 BOTTLE (71335-2122-0) | April 3, 2024 |
| 71335-2122-1 | 71335-2122 | Bryant Ranch Prepack | 5 TABLET in 1 BOTTLE (71335-2122-1) | April 3, 2024 |
| 71335-2122-2 | 71335-2122 | Bryant Ranch Prepack | 54 TABLET in 1 BOTTLE (71335-2122-2) | June 17, 2022 |
| 71335-2122-3 | 71335-2122 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-2122-3) | April 3, 2024 |
| 71335-2122-4 | 71335-2122 | Bryant Ranch Prepack | 18 TABLET in 1 BOTTLE (71335-2122-4) | April 3, 2024 |
| 71335-2122-5 | 71335-2122 | Bryant Ranch Prepack | 25 TABLET in 1 BOTTLE (71335-2122-5) | April 3, 2024 |
| 71335-2122-6 | 71335-2122 | Bryant Ranch Prepack | 26 TABLET in 1 BOTTLE (71335-2122-6) | April 3, 2024 |
| 71335-2122-7 | 71335-2122 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-2122-7) | April 3, 2024 |
| 71335-2122-8 | 71335-2122 | Bryant Ranch Prepack | 24 TABLET in 1 BOTTLE (71335-2122-8) | April 3, 2024 |
| 71335-2122-9 | 71335-2122 | Bryant Ranch Prepack | 16 TABLET in 1 BOTTLE (71335-2122-9) | April 3, 2024 |
| 71335-2134-0 | 71335-2134 | Bryant Ranch Prepack | 42 TABLET in 1 BOTTLE (71335-2134-0) | March 20, 2023 |
| 71335-2134-1 | 71335-2134 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-2134-1) | July 21, 2022 |
| 71335-2134-2 | 71335-2134 | Bryant Ranch Prepack | 78 TABLET in 1 BOTTLE (71335-2134-2) | February 25, 2025 |
| 71335-2134-3 | 71335-2134 | Bryant Ranch Prepack | 36 TABLET in 1 BOTTLE (71335-2134-3) | February 25, 2025 |
| 71335-2134-4 | 71335-2134 | Bryant Ranch Prepack | 21 TABLET in 1 BOTTLE (71335-2134-4) | July 26, 2022 |
| 71335-2134-5 | 71335-2134 | Bryant Ranch Prepack | 15 TABLET in 1 BOTTLE (71335-2134-5) | March 15, 2023 |
| 71335-2134-6 | 71335-2134 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-2134-6) | February 20, 2023 |
| 71335-2134-7 | 71335-2134 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (71335-2134-7) | June 4, 2024 |
| 71335-2134-8 | 71335-2134 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (71335-2134-8) | April 12, 2023 |
| 71335-2134-9 | 71335-2134 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-2134-9) | July 11, 2022 |
| 71335-2149-0 | 71335-2149 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-2149-0) | May 2, 2024 |
| 71335-2149-1 | 71335-2149 | Bryant Ranch Prepack | 6 TABLET in 1 BOTTLE (71335-2149-1) | October 6, 2022 |
| 71335-2149-2 | 71335-2149 | Bryant Ranch Prepack | 14 TABLET in 1 BOTTLE (71335-2149-2) | August 15, 2022 |
| 71335-2149-3 | 71335-2149 | Bryant Ranch Prepack | 5 TABLET in 1 BOTTLE (71335-2149-3) | May 29, 2024 |
| 71335-2149-4 | 71335-2149 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (71335-2149-4) | September 6, 2022 |
| 71335-2149-5 | 71335-2149 | Bryant Ranch Prepack | 8 TABLET in 1 BOTTLE (71335-2149-5) | May 29, 2024 |
| 71335-2149-6 | 71335-2149 | Bryant Ranch Prepack | 7 TABLET in 1 BOTTLE (71335-2149-6) | August 8, 2022 |
| 71335-2149-7 | 71335-2149 | Bryant Ranch Prepack | 24 TABLET in 1 BOTTLE (71335-2149-7) | May 2, 2024 |
| 71335-2149-8 | 71335-2149 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-2149-8) | May 2, 2024 |
| 71335-2149-9 | 71335-2149 | Bryant Ranch Prepack | 12 TABLET in 1 BOTTLE (71335-2149-9) | May 2, 2024 |
| 71335-2160-1 | 71335-2160 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-2160-1) | August 20, 2026 |
| 71335-2160-2 | 71335-2160 | Bryant Ranch Prepack | 5 TABLET in 1 BOTTLE (71335-2160-2) | September 27, 2022 |
| 71335-2160-3 | 71335-2160 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-2160-3) | August 20, 2026 |
| 71335-2160-4 | 71335-2160 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-2160-4) | August 20, 2026 |
| 71335-2160-5 | 71335-2160 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-2160-5) | August 20, 2026 |
| 71335-2160-6 | 71335-2160 | Bryant Ranch Prepack | 7 TABLET in 1 BOTTLE (71335-2160-6) | August 20, 2026 |
| 71335-2160-7 | 71335-2160 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (71335-2160-7) | August 20, 2026 |
| 71335-2160-8 | 71335-2160 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (71335-2160-8) | August 20, 2026 |
| 71335-2273-1 | 71335-2273 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-2273-1) | November 2, 2023 |
| 71335-2273-2 | 71335-2273 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-2273-2) | December 5, 2023 |
| 71335-2356-1 | 71335-2356 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-2356-1) | May 28, 2024 |
| 71335-2356-2 | 71335-2356 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-2356-2) | May 28, 2024 |
| 71335-2389-1 | 71335-2389 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-2389-1) | May 29, 2024 |
| 71335-2389-2 | 71335-2389 | Bryant Ranch Prepack | 5 TABLET in 1 BOTTLE (71335-2389-2) | May 29, 2024 |
| 71335-2389-3 | 71335-2389 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-2389-3) | May 29, 2024 |
| 71335-2389-4 | 71335-2389 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-2389-4) | May 29, 2024 |
| 71335-2389-5 | 71335-2389 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-2389-5) | May 29, 2024 |
| 71335-2389-6 | 71335-2389 | Bryant Ranch Prepack | 7 TABLET in 1 BOTTLE (71335-2389-6) | May 29, 2024 |
| 71335-2389-7 | 71335-2389 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (71335-2389-7) | May 29, 2024 |
| 71335-2389-8 | 71335-2389 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (71335-2389-8) | May 29, 2024 |
| 71335-2895-1 | 71335-2895 | Bryant Ranch Prepack | 9 TABLET in 1 BOTTLE (71335-2895-1) | October 28, 2025 |
| 71335-2895-2 | 71335-2895 | Bryant Ranch Prepack | 19 TABLET in 1 BOTTLE (71335-2895-2) | October 28, 2025 |
| 71335-3129-1 | 71335-3129 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-3129-1) | April 29, 2026 |
| 71335-3129-2 | 71335-3129 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE, PLASTIC (71335-3129-2) | April 29, 2026 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
| Enforcement | FDA | Recall records |
Generated September 25, 2026 · 13 sections on this page.