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Sulfamethoxazole and Trimethoprim
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 |
|---|---|---|
| Cytochrome P450 2C8 Inhibitors [MoA] | MoA | All 56 members |
| Cytochrome P450 2C9 Inhibitors [MoA] | MoA | All 34 members |
| Dihydrofolate Reductase Inhibitor Antibacterial [EPC] | EPC | 8 members — no class page |
| Dihydrofolate Reductase Inhibitors [MoA] | MoA | All 25 members |
| Organic Cation Transporter 2 Inhibitors [MoA] | MoA | All 32 members |
| Sulfonamide Antimicrobial [EPC] | EPC | 4 members — no class page |
| Sulfonamides [CS] | CS | All 18 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | TABLET | SULFAMETHOXAZOLE; TRIMETHOPRIM | Prescription | AB | ||
| 090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | TABLET | SULFAMETHOXAZOLE; TRIMETHOPRIM | 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 | 16 | Labeling | Approved | September 16, 2022 | Standard |
| Supplement | 15 | Labeling | Approved | September 16, 2022 | Standard |
| Supplement | 8 | Labeling | Approved | September 16, 2022 | Standard |
| Supplement | 5 | Labeling | Approved | December 21, 2014 | Standard |
| Supplement | 2 | Manufacturing (CMC) | Approved | January 2, 2013 | — |
| Supplement | 4 | Labeling | Approved | November 8, 2012 | Standard |
| Supplement | 1 | Labeling | Approved | October 26, 2010 | — |
| Original application | 1 | Approved | February 16, 2010 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260324). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingIndications and Usage Section INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections: For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media: For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim tablets offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim tablets in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim tablets are not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults: For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim tablets could offer some advantage over the use of a single antimicrobial agent. Shigellosis: For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis jirovecii Pneumonia: For the treatment of documented Pneumocystis jirovecii pneumonia and for prophylaxis against P. jirovecii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jirovecii pneumonia. Traveler’s Diarrhea in Adults: For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.
Dosage and Administration
openFDA Drug LabelingDOSAGE AND ADMINISTRATION Sulfamethoxazole and trimethoprim tablets, USP are contraindicated in pediatric patients less than 2 months of age. Urinary Tract Infections and Shigellosis in Adults and Pediatric Patients, and Acute Otitis Media in Children: Adults: The usual adult dosage in the treatment of urinary tract infections is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet, USP or 2 sulfamethoxazole and trimethoprim tablets, USP every 12 hours for 10 to 14 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. Children: The recommended dose for children with urinary tract infections or acute otitis media is 40 mg/kg sulfamethoxazole, USP and 8 mg/kg trimethoprim, USP per 24 hours, given in two divided doses every 12 hours for 10 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. The following table is a guideline for the attainment of this dosage: Children 2 months of age or older: Weight Dose – every 12 hours lb kg Tablets 22 10 - 44 20 1 66 30 1 1⁄2 88 40 2 or 1 DS tablet For Patients with Impaired Renal Function: When renal function is impaired, a reduced dosage should be employed using the following table: Creatinine Clearance (mL/min) Recommended Dosage Regimen Above 30 Usual standard regimen 15 to 30 1/2 the usual regimen Below 15 Use not recommended Acute Exacerbations of Chronic Bronchitis in Adults: The usual adult dosage in the treatment of acute exacerbations of chronic bronchitis is 1 sulfamethoxazole and trimethoprim double strength tablet, USP, or 2 sulfamethoxazole and trimethoprim single strength tablets, USP, every 12 hours for 14 days. Pneumocystis Jiroveci Pneumonia Treatment: Adults and Children: The recommended dosage for treatment of patients with documented Pneumocystis jiroveci pneumonia is 75 to 100 mg/kg sulfamethoxazole, USP and 15 to 20 mg/kg trimethoprim, USP per 24 hours given in equally divided doses every 6 hours for 14 to 21 days. 11 The following table is a guideline for the upper limit of this dosage: Weight Dose – every 6 hours lb kg Tablets 18 8 - 35 16 1 53 24 1 1⁄2 70 32 2 or 1 DS tablet 88 40 2 1⁄2 106 48 3 or 1 1⁄2 DS tablets 141 64 4 or 2 DS tablets 176 80 5 or 2 1⁄2 DS tablets For the lower limit dose (75 mg/kg sulfamethoxazole, USP and 15 mg/kg trimethoprim, USP per 24 hours) administer 75% of the dose in the above table. Prophylaxis Adults: The recommended dosage for prophylaxis in adults is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet, USP daily. 12 Children: For children, the recommended dose is 750 mg/m 2 /day sulfamethoxazole, USP with 150 mg/m 2 /day trimethoprim, USP given orally in equally divided doses twice a day, on 3 consecutive days per week. The total daily dose should not exceed 1600 mg sulfamethoxazole, USP and 320 mg trimethoprim, USP. 13 The following table is a guideline for the attainment of this dosage in children: Body Surface Area Dose – every 12 hours (m 2 ) Tablets 0.26 - 0.53 1⁄2 1.06 1 Traveler’s Diarrhea in Adults: For the treatment of traveler’s diarrhea, the usual adult dosage is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet, USP or 2 sulfamethoxazole and trimethoprim single strength tablets, USP every 12 hours for 5 days.
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS: Sulfamethoxazole and trimethoprim is contraindicated in patients with a known hypersensitivity to trimethoprim or sulfonamides and in patients with documented megaloblastic anemia due to folate deficiency. Sulfamethoxazole and trimethoprim is also contraindicated in pregnant patients and nursing mothers, because sulfonamides pass the placenta and are excreted in the milk and may cause kernicterus. Sulfamethoxazole and trimethoprim is contraindicated in pediatric patients less than 2 months of age. Sulfamethoxazole and trimethoprim is also contraindicated in patients with marked hepatic damage or with severe renal insufficiency when renal function status cannot be monitored.
Warnings
openFDA Drug LabelingWARNINGS Embryofetal Toxicity Some epidemiologic studies suggest that exposure to sulfamethoxazole and trimethoprim during pregnancy may be associated with an increased risk of congenital malformations, particularly neural tube defects, cardiovascular malformations, urinary tract defects, oral clefts, and club foot. If sulfamethoxazole and trimethoprim is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be advised of the potential hazards to the fetus (see PRECAUTIONS). Hypersensitivity and Other Serious or Fatal Reactions Fatalities and serious adverse reactions including severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute febrile neutrophilic dermatosis (AFND), acute generalized erythematous pustulosis (AGEP); fulminant hepatic necrosis; agranulocytosis, aplastic anemia and other blood dyscrasias; acute and delayed lung injury; anaphylaxis and circulatory shock have occurred with the administration of sulfamethoxazole and trimethoprim products, including sulfamethoxazole and trimethoprim (see ADVERSE REACTIONS). Hypersensitivity Reactions of the Respiratory Tract Cough, shortness of breath and pulmonary infiltrates potentially representing hypersensitivity reactions of the respiratory tract have been reported in association with sulfamethoxazole and trimethoprim treatment. Respiratory Failure Other severe pulmonary adverse reactions occurring within days to week of sulfamethoxazole and trimethoprim initiation and resulting in prolonged respiratory failure requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO), lung transplantation or death have also been reported in patients and otherwise healthy individuals treated with sulfamethoxazole and trimethoprim products. Circulatory Shock Circulatory shock with fever, severe hypotension, and confusion requiring intravenous fluid resuscitation and vasopressors has occurred within minutes to hours of re-challenge with sulfamethoxazole and trimethoprim products, including sulfamethoxazole and trimethoprim, in patients with history of recent (days to weeks) exposure to sulfamethoxazole and trimethoprim. Management of Hypersensitivity and Other Serious Reactions Sulfamethoxazole and trimethoprim should be discontinued at the first appearance of skin rash or any sign of a serious adverse reaction. A skin rash may be followed by a more severe reaction, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, AFND, AGEP, hepatic necrosis, or serious blood disorders (see PRECAUTIONS and ADVERSE REACTIONS). Clinical signs, such as rash, pharyngitis, fever, arthralgia, cough, chest pain, dyspnea, pallor, purpura or jaundice may be early indications of serious reactions. Hemophagocytic Lymphohistiocytosis Cases of hemophagocytic lymphohistiocytosis (HLH) have been reported in patients treated with sulfamethoxazole-trimethoprim. HLH is a life-threatening syndrome of pathologic immune activation characterized by clinical signs and symptoms of extreme systemic inflammation. Signs and symptoms of HLH may include fever, hepatosplenomegaly, rash, lymphadenopathy, neurologic symptoms, cytopenias, high serum ferritin, hypertriglyceridemia, and liver enzyme and coagulation abnormalities. If HLH is suspected, discontinue sulfamethoxazole and trimethoprim immediately and institute appropriate management. Thrombocytopenia Sulfamethoxazole and trimethoprim-induced thrombocytopenia may be an immune-mediated disorder. Severe cases of thrombocytopenia that are fatal or life threatening have been reported. Thrombocytopenia usually resolves within a week upon discontinuation of sulfamethoxazole and trimethoprim. Streptococcal Infections and Rheumatic Fever The sulfonamides should not be used for treatment of group Aβ-hemolytic streptococcal infections. In an established infection, they will not eradica …
Adverse Reactions
openFDA Drug LabelingADVERSE REACTIONS The following adverse reactions associated with the use of sulfamethoxazole and trimethoprim were identified in clinical trials, postmarketing or published reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most common adverse reactions are gastrointestinal disturbances (nausea, vomiting, anorexia) and allergic skin reactions (such as rash and urticaria). Fatalities and serious adverse reactions, including severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute febrile neutrophilic dermatosis (AFND), acute generalized erythematous pustulosis (AGEP); fulminant hepatic necrosis; agranulocytosis, aplastic anemia and other blood dyscrasias; acute and delayed lung injury; anaphylaxis and circulatory shock have occurred with the administration of sulfamethoxazole and trimethoprim products, including sulfamethoxazole and trimethoprim (see WARNINGS). Hematologic: Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia, megaloblastic anemia, hypoprothrombinemia, methemoglobinemia, eosinophilia, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura. Allergic/Immune Reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, allergic myocarditis, erythema multiforme, exfoliative dermatitis, angioedema, drug fever, chills, Henoch-Schoenlein purpura, serum sickness-like syndrome, generalized allergic reactions, generalized skin eruptions, photosensitivity, conjunctival and scleral injection, pruritus, urticaria, rash, periarteritis nodosa, hemophagocytic lymphohistio cytosis (HLH), systemic lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized erythematous pustulosis (AGEP), and acute febrile neutrophilic dermatosis (AFND) (see WARNINGS). Gastrointestinal: Hepatitis (including cholestatic jaundice and hepatic necrosis), elevation of serum transaminase and bilirubin, pseudomembranous enterocolitis, pancreatitis, stomatitis, glossitis, nausea, emesis, abdominal pain, diarrhea, anorexia. Genitourinary: Renal failure, interstitial nephritis, BUN and serum creatinine elevation, renal insufficiency, oliguria and anuria, crystalluria and nephrotoxicity in association with cyclosporine. Metabolic and Nutritional: Hyperkalemia, hyponatremia (see PRECAUTIONS: Electrolyte Abnormalities), metabolic acidosis. Neurologic: Aseptic meningitis, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, headache. Psychiatric: Hallucinations, depression, apathy, nervousness. Endocrine: The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemic agents. Cross-sensitivity may exist with these agents. Diuresis and hypoglycemia have occurred. Musculoskeletal: Arthralgia, myalgia, rhabdomyolysis. Respiratory: Cough, shortness of breath and pulmonary infiltrates, acute eosinophilic pneumonia, acute and delayed lung injury, interstitial lung disease, acute respiratory failure (see WARNINGS). Cardiovascular System: QT prolongation resulting in ventricular tachycardia and torsades de pointes, circulatory shock (see WARNINGS). Miscellaneous: Weakness, fatigue, insomnia. To report SUSPECTED ADVERSE REACTIONS contact AvKARE at 1-855-361-3993; email drugsafety@avkare.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
openFDA Drug LabelingDrug Interactions Potential for Sulfamethoxazole and Trimethoprim to Affect Other Drugs Trimethoprim is an inhibitor of CYP2C8 as well as OCT2 transporter. Sulfamethoxazole is an inhibitor of CYP2C9. Avoid coadministration of sulfamethoxazole and trimethoprim with drugs that are substrates of CYP2C8 and 2C9 or OCT2. Table 1: Drug Interactions with Sulfamethoxazole and Trimethoprim Drug(s) Recommendation Comments Diuretics Avoid concurrent use In elderly patients concurrently receiving certain diuretics, primarily thiazides, an increased incidence of thrombocytopenia with purpura has been reported. Warfarin Monitor prothrombin time and INR It has been reported that sulfamethoxazole and trimethoprim may prolong the prothrombin time in patients who are receiving the anticoagulant warfarin (a CYP2C9 substrate). This interaction should be kept in mind when sulfamethoxazole and trimethoprim is given to patients already on anticoagulant therapy, and the coagulation time should be reassessed. Phenytoin Monitor serum phenytoin levels Sulfamethoxazole and trimethoprim may inhibit the hepatic metabolism of phenytoin (a CYP2C9 substrate). Sulfamethoxazole and trimethoprim, given at a common clinical dosage, increased the phenytoin half-life by 39% and decreased the phenytoin metabolic clearance rate by 27%. When administering these drugs concurrently, one should be alert for possible excessive phenytoin effect. Methotrexate Avoid concurrent use Sulfonamides can also displace methotrexate from plasma protein binding sites and can compete with the renal transport of methotrexate, thus increasing free methotrexate concentrations. Cyclosporine Avoid concurrent use There have been reports of marked but reversible nephrotoxicity with coadministration of sulfamethoxazole and trimethoprim and cyclosporine in renal transplant recipients. Digoxin Monitor serum digoxin levels Increased digoxin blood levels can occur with concomitant sulfamethoxazole and trimethoprim therapy, especially in elderly patients. Indomethacin Avoid concurrent use Increased sulfamethoxazole blood levels may occur in patients who are also receiving indomethacin. Pyrimethamine Avoid concurrent use Occasional reports suggest that patients receiving pyrimethamine as malaria prophylaxis in doses exceeding 25 mg weekly may develop megaloblastic anemia if sulfamethoxazole and trimethoprim is prescribed. Tricyclic Antidepressants (TCAs) Monitor therapeutic response and adjust dose of TCA accordingly The efficacy of tricyclic antidepressants can decrease when coadministered with sulfamethoxazole and trimethoprim. Oral Hypoglycemics Monitor blood glucose more frequently Like other sulfonamide-containing drugs, sulfamethoxazole and trimethoprim potentiates the effect of oral hypoglycemic that are metabolized by CYP2C8 (e.g., pioglitazone, repaglinide, and rosiglitazone) or CYP2C9 (e.g., glipizide and glyburide) or eliminated renally via OCT2 (e.g., metformin). Additional monitoring of blood glucose may be warranted. Amantadine Avoid concurrent use In the literature, a single case of toxic delirium has been reported after concomitant intake of sulfamethoxazole and trimethoprim and amantadine (an OCT2 substrate). Cases of interactions with other OCT2 substrates, memantine and metformin, have also been reported. Angiotensin Converting Enzyme Inhibitors Avoid concurrent use In the literature, three cases of hyperkalemia in elderly patients have been reported after concomitant intake of sulfamethoxazole and trimethoprim and an angiotensin converting enzyme inhibitor. 5,6 Zidovudine Monitor for hematologic toxicity Zidovudine and sulfamethoxazole and trimethoprim are known to induce hematological abnormalities. Hence, there is potential for an additive myelotoxicity when coadministered. 7 Dofetilide Concurrent administration is contraindicated Elevated plasma concentrations of dofetilide have been reported following concurrent administration of trimethoprim and dofetilide. Increased plasma …
Description
openFDA Drug LabelingDESCRIPTION: Sulfamethoxazole and Trimethoprim is a synthetic antibacterial combination product available in 800 mg sulfamethoxazole and 160 mg trimethoprim Double Strength tablets and 400 mg sulfamethoxazole and 80 mg trimethoprim tablets for oral administration. Each Double Strength tablet contains 800 mg sulfamethoxazole and 160 mg trimethoprim plus magnesium stearate, pregelatinized starch and sodium starch glycolate. Each tablet contains 400 mg sulfamethoxazole and 80 mg trimethoprim plus magnesium stearate, pregelatinized starch, and sodium starch glycolate. Trimethoprim is 2, 4-diamino-5-(3,4,5 trimethoxybenzyl) pyrimidine: the molecular formula is C 14 H 18 N 4 O 3 . It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula: Sulfamethoxazole is N 1 -(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10 H 11 N 3 O 3 S. It is almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula: chemical structure chemical structure
Overdosage
openFDA Drug LabelingOVERDOSAGE Acute The amount of a single dose of sulfamethoxazole and trimethoprim tablets that is either associated with symptoms of overdosage or is likely to be life-threatening has not been reported. Signs and symptoms of overdosage reported with sulfonamides include anorexia, colic, nausea, vomiting, dizziness, headache, drowsiness and unconsciousness. Pyrexia, hematuria and crystalluria may be noted. Blood dyscrasias and jaundice are potential late manifestations of overdosage. Signs of acute overdosage with trimethoprim include nausea, vomiting, dizziness, headache, mental depression, confusion and bone marrow depression. General principles of treatment include the institution of gastric lavage or emesis, forcing oral fluids, and the administration of intravenous fluids if urine output is low and renal function is normal. Acidification of the urine will increase renal elimination of trimethoprim. The patient should be monitored with blood counts and appropriate blood chemistries, including electrolytes. If a significant blood dyscrasia or jaundice occurs, specific therapy should be instituted for these complications. Peritoneal dialysis is not effective and hemodialysis is only moderately effective in eliminating sulfamethoxazole and trimethoprim. Chronic Use of sulfamethoxazole and trimethoprim tablets at high doses and/or for extended periods of time may cause bone marrow depression manifested as thrombocytopenia, leukopenia and/or megaloblastic anemia. If signs of bone marrow depression occur, the patient should be given leucovorin 5 to 15 mg daily until normal hematopoiesis is restored.
How Supplied / Storage and Handling
openFDA Drug LabelingHow Supplied/Storage and Handling Sulfamethoxazole and trimethoprim is contraindicated in pediatric patients less than 2 months of age. Urinary Tract Infections and Shigellosis in Adults and Pediatric Patients, and Acute Otitis Media in Children Adults: The usual adult dosage in the treatment of urinary tract infections is 1 sulfamethoxazole and trimethoprim double strength tablet or 2 sulfamethoxazole and trimethoprim tablets every 12 hours for 10 to 14 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. Children: The recommended dose for children with urinary tract infections or acute otitis media is 40 mg/kg sulfamethoxazole and 8 mg/kg trimethoprim per 24 hours, given in two divided doses every 12 hours for 10 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. The following table is a guideline for the attainment of this dosage: Children 2 months of age or older: Weight Dose – every 12 hours lb kg Tablets 22 10 - 44 20 1 66 30 11⁄2 88 40 2 or 1 DS tablet For Patients with Impaired Renal Function When renal function is impaired, a reduced dosage should be employed using the following table: Creatinine Clearance (mL/min) Recommended Dosage Regimen Above 30 Usual standard regimen 15 to 30 1⁄2 the usual regimen Below 15 Use not recommended Acute Exacerbations of Chronic Bronchitis in Adults The usual adult dosage in the treatment of acute exacerbations of chronic bronchitis is 1 sulfamethoxazole and trimethoprim double strength tablet or 2 sulfamethoxazole and trimethoprim single strength tablets every 12 hours for 14 days. Pneumocystis Jirovecii Pneumonia Treatment Adults and Children The recommended dosage for treatment of patients with documented Pneumocystis jirovecii pneumonia is 75 mg/kg to 100 mg/kg sulfamethoxazole and 15 mg/kg to 20 mg/kg trimethoprim per 24 hours given in equally divided doses every 6 hours for 14 to 21 days12. The following table is a guideline for the upper limit of this dosage: Weight Dose – every 6 hours lb kg Tablets 18 8 - 35 16 1 53 24 11⁄2 70 32 2 or 1 DS tablet 88 40 21⁄2 106 48 3 or 11⁄2 DS tablets 141 64 4 or 2 DS tablets 176 80 5 or 21⁄2 DS tablets For the lower limit dose (75 mg/kg sulfamethoxazole and 15 mg/kg trimethoprim per 24 hours) administer 75% of the dose in the above table. Prophylaxis Adults: The recommended dosage for prophylaxis in adults is 1 sulfamethoxazole and trimethoprim double strength tablet daily13. Children: For children, the recommended dose is 750 mg/m2/day sulfamethoxazole with 150 mg/m2/day trimethoprim given orally in equally divided doses twice a day, on 3 consecutive days per week. The total daily dose should not exceed 1,600 mg sulfamethoxazole and 320 mg trimethoprim14. The following table is a guideline for the attainment of this dosage in children: Body Surface Area Dose – every 12 hours (m2) Tablets 0.26 - 0.53 1⁄2 1.06 1 Traveler’s Diarrhea in Adults For the treatment of traveler’s diarrhea, the usual adult dosage is 1 sulfamethoxazole and trimethoprim double strength tablet or 2 sulfamethoxazole and trimethoprim single strength tablets every 12 hours for 5 days.
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: TRIMETHOPRIM. 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 | September 24, 2025 | Northwind Pharmaceuticals LLC | Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Ongoing |
| Class II | September 17, 2025 | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories | Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Ongoing |
| Class II | September 17, 2025 | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories | Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Ongoing |
| Class II | September 10, 2025 | Amneal Pharmaceuticals, LLC | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Ongoing |
| Class I | June 18, 2025 | Amneal Pharmaceuticals, LLC | Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination. | Ongoing |
| Class II | June 15, 2022 | Mckesson Medical-Surgical Inc. Corporate Office | cGMP deviations: Temperature abuse | Terminated |
| Class II | August 18, 2021 | Aurobindo Pharma USA Inc. | Presence of Foreign Substance- Potential of metal contamination. | Terminated |
| Class II | September 2, 2020 | Aurobindo Pharma USA Inc. | Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s). | Terminated |
| Class II | May 23, 2018 | Sun Pharmaceutical Industries, Inc. | Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as polyethylene was detected in two (2) tablets. | Terminated |
| Class II | July 30, 2014 | Shamrock Medical Solutions Group LLC | Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg | Terminated |
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-2198-0 | 50090-2198 | A-S Medication Solutions | 10 TABLET in 1 BOTTLE (50090-2198-0) | October 28, 2015 |
| 50090-2198-1 | 50090-2198 | A-S Medication Solutions | 14 TABLET in 1 BOTTLE (50090-2198-1) | October 28, 2015 |
| 50090-2198-2 | 50090-2198 | A-S Medication Solutions | 20 TABLET in 1 BOTTLE (50090-2198-2) | October 28, 2015 |
| 50090-2198-3 | 50090-2198 | A-S Medication Solutions | 28 TABLET in 1 BOTTLE (50090-2198-3) | October 28, 2015 |
| 50090-2198-5 | 50090-2198 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-2198-5) | October 28, 2015 |
| 50090-2198-7 | 50090-2198 | A-S Medication Solutions | 6 TABLET in 1 BOTTLE (50090-2198-7) | October 28, 2015 |
| 50090-2199-0 | 50090-2199 | A-S Medication Solutions | 40 TABLET in 1 BOTTLE (50090-2199-0) | October 28, 2015 |
| 50090-2199-1 | 50090-2199 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-2199-1) | October 28, 2015 |
| 50090-2200-0 | 50090-2200 | A-S Medication Solutions | 20 TABLET in 1 BOTTLE (50090-2200-0) | October 28, 2015 |
| 50090-2200-1 | 50090-2200 | A-S Medication Solutions | 14 TABLET in 1 BOTTLE (50090-2200-1) | December 13, 2023 |
| 50090-2201-0 | 50090-2201 | A-S Medication Solutions | 6 TABLET in 1 BOTTLE (50090-2201-0) | October 28, 2015 |
| 50090-2479-2 | 50090-2479 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-2479-2) | October 3, 2016 |
| 50090-4847-0 | 50090-4847 | A-S Medication Solutions | 10 TABLET in 1 BOTTLE (50090-4847-0) | January 20, 2020 |
| 50090-4847-1 | 50090-4847 | A-S Medication Solutions | 14 TABLET in 1 BOTTLE (50090-4847-1) | January 20, 2020 |
| 50090-4847-2 | 50090-4847 | A-S Medication Solutions | 20 TABLET in 1 BOTTLE (50090-4847-2) | January 20, 2020 |
| 50090-4847-3 | 50090-4847 | A-S Medication Solutions | 28 TABLET in 1 BOTTLE (50090-4847-3) | January 20, 2020 |
| 50090-4847-5 | 50090-4847 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-4847-5) | January 20, 2020 |
| 50090-4847-7 | 50090-4847 | A-S Medication Solutions | 6 TABLET in 1 BOTTLE (50090-4847-7) | January 20, 2020 |
| 50090-4848-2 | 50090-4848 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-4848-2) | January 20, 2020 |
| 50090-4850-0 | 50090-4850 | A-S Medication Solutions | 40 TABLET in 1 BOTTLE (50090-4850-0) | January 20, 2020 |
| 50090-4850-1 | 50090-4850 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-4850-1) | January 20, 2020 |
| 50090-5679-0 | 50090-5679 | A-S Medication Solutions | 10 TABLET in 1 BOTTLE (50090-5679-0) | September 21, 2021 |
| 50090-5679-1 | 50090-5679 | A-S Medication Solutions | 14 TABLET in 1 BOTTLE (50090-5679-1) | September 21, 2021 |
| 50090-5679-2 | 50090-5679 | A-S Medication Solutions | 20 TABLET in 1 BOTTLE (50090-5679-2) | September 21, 2021 |
| 50090-5679-3 | 50090-5679 | A-S Medication Solutions | 28 TABLET in 1 BOTTLE (50090-5679-3) | September 21, 2021 |
| 50090-5679-5 | 50090-5679 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-5679-5) | September 21, 2021 |
| 50090-5679-7 | 50090-5679 | A-S Medication Solutions | 6 TABLET in 1 BOTTLE (50090-5679-7) | September 21, 2021 |
| 50090-5680-2 | 50090-5680 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-5680-2) | September 21, 2021 |
| 50090-5682-0 | 50090-5682 | A-S Medication Solutions | 40 TABLET in 1 BOTTLE (50090-5682-0) | September 21, 2021 |
| 50090-5682-1 | 50090-5682 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-5682-1) | September 21, 2021 |
| 50090-6901-0 | 50090-6901 | A-S Medication Solutions | 10 TABLET in 1 BOTTLE (50090-6901-0) | December 12, 2023 |
| 50090-6901-1 | 50090-6901 | A-S Medication Solutions | 14 TABLET in 1 BOTTLE (50090-6901-1) | December 12, 2023 |
| 50090-6901-2 | 50090-6901 | A-S Medication Solutions | 20 TABLET in 1 BOTTLE (50090-6901-2) | December 12, 2023 |
| 50090-6901-3 | 50090-6901 | A-S Medication Solutions | 28 TABLET in 1 BOTTLE (50090-6901-3) | December 12, 2023 |
| 50090-6901-5 | 50090-6901 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-6901-5) | December 12, 2023 |
| 50090-6901-7 | 50090-6901 | A-S Medication Solutions | 6 TABLET in 1 BOTTLE (50090-6901-7) | December 12, 2023 |
| 50090-6902-2 | 50090-6902 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-6902-2) | December 12, 2023 |
| 50090-6904-0 | 50090-6904 | A-S Medication Solutions | 40 TABLET in 1 BOTTLE (50090-6904-0) | December 12, 2023 |
| 50090-6904-1 | 50090-6904 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-6904-1) | December 12, 2023 |
| 50090-7008-0 | 50090-7008 | A-S Medication Solutions | 100 BLISTER PACK in 1 CARTON (50090-7008-0) / 1 TABLET in 1 BLISTER PACK | January 4, 2024 |
| 50090-7393-1 | 50090-7393 | A-S Medication Solutions | 14 TABLET in 1 BOTTLE (50090-7393-1) | October 23, 2024 |
| 50090-7399-0 | 50090-7399 | A-S Medication Solutions | 6 TABLET in 1 BOTTLE (50090-7399-0) | October 23, 2024 |
| 80425-0001-1 | 80425-0001 | Advanced Rx Pharmacy of Tennessee, LLC | 14 TABLET in 1 BOTTLE (80425-0001-1) | September 13, 2010 |
| 80425-0002-1 | 80425-0002 | Advanced Rx Pharmacy of Tennessee, LLC | 14 TABLET in 1 BOTTLE (80425-0002-1) | February 16, 2010 |
| 80425-0003-1 | 80425-0003 | Advanced Rx Pharmacy of Tennessee, LLC | 14 TABLET in 1 BOTTLE (80425-0003-1) | February 16, 2010 |
| 80425-0003-2 | 80425-0003 | Advanced Rx Pharmacy of Tennessee, LLC | 20 TABLET in 1 BOTTLE (80425-0003-2) | February 16, 2010 |
| 80425-0003-3 | 80425-0003 | Advanced Rx Pharmacy of Tennessee, LLC | 30 TABLET in 1 BOTTLE (80425-0003-3) | February 16, 2010 |
| 80425-0003-4 | 80425-0003 | Advanced Rx Pharmacy of Tennessee, LLC | 10 TABLET in 1 BOTTLE (80425-0003-4) | February 16, 2010 |
| 60687-614-01 | 60687-614 | American Health Packaging | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-614-01) / 1 TABLET in 1 BLISTER PACK (60687-614-11) | January 3, 2022 |
| 65162-271-05 | 65162-271 | Amneal Pharmaceuticals LLC | 50 TABLET in 1 BOTTLE (65162-271-05) | February 25, 2010 |
| 65162-271-10 | 65162-271 | Amneal Pharmaceuticals LLC | 100 TABLET in 1 BOTTLE (65162-271-10) | February 25, 2010 |
| 65162-271-11 | 65162-271 | Amneal Pharmaceuticals LLC | 1000 TABLET in 1 BOTTLE (65162-271-11) | February 25, 2010 |
| 65162-271-50 | 65162-271 | Amneal Pharmaceuticals LLC | 500 TABLET in 1 BOTTLE (65162-271-50) | February 25, 2010 |
| 65162-272-01 | 65162-272 | Amneal Pharmaceuticals LLC | 10 TABLET in 1 BOTTLE (65162-272-01) | September 13, 2010 |
| 65162-272-10 | 65162-272 | Amneal Pharmaceuticals LLC | 100 TABLET in 1 BOTTLE (65162-272-10) | September 13, 2010 |
| 65162-272-24 | 65162-272 | Amneal Pharmaceuticals LLC | 24 TABLET in 1 BOTTLE (65162-272-24) | September 13, 2010 |
| 65162-272-25 | 65162-272 | Amneal Pharmaceuticals LLC | 250 TABLET in 1 BOTTLE (65162-272-25) | September 13, 2010 |
| 65162-272-50 | 65162-272 | Amneal Pharmaceuticals LLC | 500 TABLET in 1 BOTTLE (65162-272-50) | September 13, 2010 |
| 53746-271-01 | 53746-271 | Amneal Pharmaceuticals of New York LLC | 100 TABLET in 1 BOTTLE (53746-271-01) | February 25, 2010 |
| 53746-271-05 | 53746-271 | Amneal Pharmaceuticals of New York LLC | 500 TABLET in 1 BOTTLE (53746-271-05) | February 25, 2010 |
| 53746-271-10 | 53746-271 | Amneal Pharmaceuticals of New York LLC | 1000 TABLET in 1 BOTTLE (53746-271-10) | February 25, 2010 |
| 53746-271-50 | 53746-271 | Amneal Pharmaceuticals of New York LLC | 50 TABLET in 1 BOTTLE (53746-271-50) | February 25, 2010 |
| 53746-272-01 | 53746-272 | Amneal Pharmaceuticals of New York LLC | 100 TABLET in 1 BOTTLE (53746-272-01) | September 13, 2010 |
| 53746-272-02 | 53746-272 | Amneal Pharmaceuticals of New York LLC | 250 TABLET in 1 BOTTLE (53746-272-02) | September 13, 2010 |
| 53746-272-05 | 53746-272 | Amneal Pharmaceuticals of New York LLC | 500 TABLET in 1 BOTTLE (53746-272-05) | September 13, 2010 |
| 53746-272-11 | 53746-272 | Amneal Pharmaceuticals of New York LLC | 10 TABLET in 1 BOTTLE (53746-272-11) | September 13, 2010 |
| 53746-272-24 | 53746-272 | Amneal Pharmaceuticals of New York LLC | 24 TABLET in 1 BOTTLE (53746-272-24) | September 13, 2010 |
| 76420-064-06 | 76420-064 | Asclemed USA, Inc. | 6 TABLET in 1 BOTTLE (76420-064-06) | September 4, 2020 |
| 76420-064-10 | 76420-064 | Asclemed USA, Inc. | 10 TABLET in 1 BOTTLE (76420-064-10) | September 4, 2020 |
| 76420-064-14 | 76420-064 | Asclemed USA, Inc. | 14 TABLET in 1 BOTTLE (76420-064-14) | February 11, 2020 |
| 76420-064-20 | 76420-064 | Asclemed USA, Inc. | 20 TABLET in 1 BOTTLE (76420-064-20) | February 11, 2020 |
| 76420-064-28 | 76420-064 | Asclemed USA, Inc. | 28 TABLET in 1 BOTTLE (76420-064-28) | February 11, 2020 |
| 76420-064-30 | 76420-064 | Asclemed USA, Inc. | 30 TABLET in 1 BOTTLE (76420-064-30) | September 4, 2020 |
| 65862-419-01 | 65862-419 | Aurobindo Pharma Limited | 100 TABLET in 1 BOTTLE (65862-419-01) | February 16, 2010 |
| 65862-419-05 | 65862-419 | Aurobindo Pharma Limited | 500 TABLET in 1 BOTTLE (65862-419-05) | February 16, 2010 |
| 65862-419-20 | 65862-419 | Aurobindo Pharma Limited | 20 TABLET in 1 BOTTLE (65862-419-20) | February 16, 2010 |
| 65862-419-25 | 65862-419 | Aurobindo Pharma Limited | 25000 TABLET in 1 BAG (65862-419-25) | July 24, 2019 |
| 65862-419-39 | 65862-419 | Aurobindo Pharma Limited | 3000 TABLET in 1 BAG (65862-419-39) | February 16, 2010 |
| 65862-419-99 | 65862-419 | Aurobindo Pharma Limited | 1000 TABLET in 1 BOTTLE (65862-419-99) | February 16, 2010 |
| 65862-420-01 | 65862-420 | Aurobindo Pharma Limited | 100 TABLET in 1 BOTTLE (65862-420-01) | February 16, 2010 |
| 65862-420-05 | 65862-420 | Aurobindo Pharma Limited | 500 TABLET in 1 BOTTLE (65862-420-05) | February 16, 2010 |
| 65862-420-12 | 65862-420 | Aurobindo Pharma Limited | 12500 TABLET in 1 BAG (65862-420-12) | July 24, 2019 |
| 65862-420-15 | 65862-420 | Aurobindo Pharma Limited | 1500 TABLET in 1 BAG (65862-420-15) | February 16, 2010 |
| 65862-420-20 | 65862-420 | Aurobindo Pharma Limited | 20 TABLET in 1 BOTTLE (65862-420-20) | February 16, 2010 |
| 65862-420-99 | 65862-420 | Aurobindo Pharma Limited | 1000 TABLET in 1 BOTTLE (65862-420-99) | February 16, 2010 |
| 42291-758-01 | 42291-758 | AvKARE | 100 TABLET in 1 BOTTLE (42291-758-01) | August 5, 2015 |
| 42291-758-50 | 42291-758 | AvKARE | 500 TABLET in 1 BOTTLE (42291-758-50) | October 31, 2016 |
| 42291-759-01 | 42291-759 | AvKARE | 100 TABLET in 1 BOTTLE (42291-759-01) | October 31, 2016 |
| 42291-759-50 | 42291-759 | AvKARE | 500 TABLET in 1 BOTTLE (42291-759-50) | August 5, 2015 |
| 50268-728-15 | 50268-728 | AvPAK | 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-728-15) / 1 TABLET in 1 BLISTER PACK (50268-728-11) | September 23, 2014 |
| 63629-1765-0 | 63629-1765 | Bryant Ranch Prepack | 21 TABLET in 1 BOTTLE (63629-1765-0) | September 17, 2010 |
| 63629-1765-1 | 63629-1765 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (63629-1765-1) | October 9, 2024 |
| 63629-1765-2 | 63629-1765 | Bryant Ranch Prepack | 14 TABLET in 1 BOTTLE (63629-1765-2) | October 9, 2024 |
| 63629-1765-3 | 63629-1765 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (63629-1765-3) | October 9, 2024 |
| 63629-1765-4 | 63629-1765 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE (63629-1765-4) | October 9, 2024 |
| 63629-1765-5 | 63629-1765 | Bryant Ranch Prepack | 40 TABLET in 1 BOTTLE (63629-1765-5) | October 9, 2024 |
| 63629-1765-6 | 63629-1765 | Bryant Ranch Prepack | 6 TABLET in 1 BOTTLE (63629-1765-6) | October 9, 2024 |
| 63629-1765-7 | 63629-1765 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (63629-1765-7) | October 9, 2024 |
| 63629-1765-8 | 63629-1765 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (63629-1765-8) | October 9, 2024 |
| 63629-1765-9 | 63629-1765 | Bryant Ranch Prepack | 13 TABLET in 1 BOTTLE (63629-1765-9) | October 9, 2024 |
| 71335-0762-0 | 71335-0762 | Bryant Ranch Prepack | 21 TABLET in 1 BOTTLE (71335-0762-0) | July 24, 2020 |
| 71335-0762-1 | 71335-0762 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (71335-0762-1) | June 19, 2018 |
| 71335-0762-2 | 71335-0762 | Bryant Ranch Prepack | 14 TABLET in 1 BOTTLE (71335-0762-2) | April 5, 2018 |
| 71335-0762-3 | 71335-0762 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (71335-0762-3) | March 29, 2018 |
| 71335-0762-4 | 71335-0762 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE (71335-0762-4) | March 26, 2018 |
| 71335-0762-5 | 71335-0762 | Bryant Ranch Prepack | 40 TABLET in 1 BOTTLE (71335-0762-5) | April 24, 2018 |
| 71335-0762-6 | 71335-0762 | Bryant Ranch Prepack | 6 TABLET in 1 BOTTLE (71335-0762-6) | November 4, 2019 |
| 71335-0762-7 | 71335-0762 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-0762-7) | November 10, 2020 |
| 71335-0762-8 | 71335-0762 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-0762-8) | June 18, 2018 |
| 71335-0762-9 | 71335-0762 | Bryant Ranch Prepack | 13 TABLET in 1 BOTTLE (71335-0762-9) | October 7, 2024 |
| 55154-2580-0 | 55154-2580 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-2580-0) / 1 TABLET in 1 BLISTER PACK | March 23, 2026 |
| 55154-7895-0 | 55154-7895 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-7895-0) / 1 TABLET in 1 BLISTER PACK | September 13, 2010 |
| 62135-897-18 | 62135-897 | Chartwell RX, LLC | 180 TABLET in 1 BOTTLE (62135-897-18) | January 11, 2024 |
| 62135-897-90 | 62135-897 | Chartwell RX, LLC | 90 TABLET in 1 BOTTLE (62135-897-90) | January 11, 2024 |
| 62135-898-18 | 62135-898 | Chartwell RX, LLC | 180 TABLET in 1 BOTTLE (62135-898-18) | January 11, 2024 |
| 62135-898-90 | 62135-898 | Chartwell RX, LLC | 90 TABLET in 1 BOTTLE (62135-898-90) | January 11, 2024 |
| 67046-0295-3 | 67046-0295 | Coupler LLC | 30 TABLET in 1 BLISTER PACK (67046-0295-3) | May 11, 2026 |
| 69043-010-01 | 69043-010 | Cronus Pharma LLC | 100 TABLET in 1 BOTTLE (69043-010-01) | February 16, 2010 |
| 69043-010-05 | 69043-010 | Cronus Pharma LLC | 500 TABLET in 1 BOTTLE (69043-010-05) | February 16, 2010 |
| 69043-011-01 | 69043-011 | Cronus Pharma LLC | 100 TABLET in 1 BOTTLE (69043-011-01) | February 16, 2010 |
| 69043-011-05 | 69043-011 | Cronus Pharma LLC | 500 TABLET in 1 BOTTLE (69043-011-05) | February 16, 2010 |
| 70934-544-06 | 70934-544 | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | 6 TABLET in 1 BOTTLE, PLASTIC (70934-544-06) | February 12, 2020 |
| 70934-544-14 | 70934-544 | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | 14 TABLET in 1 BOTTLE, PLASTIC (70934-544-14) | February 18, 2020 |
| 70934-544-20 | 70934-544 | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | 20 TABLET in 1 BOTTLE, PLASTIC (70934-544-20) | February 18, 2020 |
| 70934-544-28 | 70934-544 | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | 28 TABLET in 1 BOTTLE, PLASTIC (70934-544-28) | March 19, 2020 |
| 60429-259-01 | 60429-259 | Golden State Medical Supply, Inc. | 100 TABLET in 1 BOTTLE, PLASTIC (60429-259-01) | April 24, 2015 |
| 0904-2725-61 | 0904-2725 | Major Pharmaceuticals | 100 BLISTER PACK in 1 CARTON (0904-2725-61) / 1 TABLET in 1 BLISTER PACK | September 13, 2010 |
| 0615-8121-10 | 0615-8121 | NCS HealthCare of KY, LLC dba Vangard Labs | 10 TABLET in 1 BLISTER PACK (0615-8121-10) | February 16, 2010 |
| 0615-8121-14 | 0615-8121 | NCS HealthCare of KY, LLC dba Vangard Labs | 14 TABLET in 1 BLISTER PACK (0615-8121-14) | February 16, 2010 |
| 0615-8121-20 | 0615-8121 | NCS HealthCare of KY, LLC dba Vangard Labs | 20 TABLET in 1 BLISTER PACK (0615-8121-20) | January 30, 2024 |
| 0615-8121-39 | 0615-8121 | NCS HealthCare of KY, LLC dba Vangard Labs | 30 TABLET in 1 BLISTER PACK (0615-8121-39) | January 30, 2024 |
| 51655-188-20 | 51655-188 | Northwind Health Company, LLC | 20 TABLET in 1 BOTTLE, PLASTIC (51655-188-20) | March 23, 2023 |
| 51655-188-53 | 51655-188 | Northwind Health Company, LLC | 10 TABLET in 1 BOTTLE, PLASTIC (51655-188-53) | April 3, 2023 |
| 51655-188-84 | 51655-188 | Northwind Health Company, LLC | 14 TABLET in 1 BOTTLE, PLASTIC (51655-188-84) | March 23, 2023 |
| 51655-188-87 | 51655-188 | Northwind Health Company, LLC | 6 TABLET in 1 BOTTLE, PLASTIC (51655-188-87) | March 23, 2023 |
| 51655-307-20 | 51655-307 | Northwind Health Company, LLC | 20 TABLET in 1 BOTTLE, PLASTIC (51655-307-20) | November 17, 2022 |
| 51655-307-29 | 51655-307 | Northwind Health Company, LLC | 28 TABLET in 1 BOTTLE, PLASTIC (51655-307-29) | February 3, 2023 |
| 51655-307-53 | 51655-307 | Northwind Health Company, LLC | 10 TABLET in 1 BOTTLE, PLASTIC (51655-307-53) | January 2, 2023 |
| 51655-307-84 | 51655-307 | Northwind Health Company, LLC | 14 TABLET in 1 BOTTLE, PLASTIC (51655-307-84) | November 17, 2022 |
| 51655-307-87 | 51655-307 | Northwind Health Company, LLC | 6 TABLET in 1 BOTTLE, PLASTIC (51655-307-87) | January 12, 2023 |
| 82868-092-28 | 82868-092 | Northwind Health Company, LLC | 28 TABLET in 1 BOTTLE, PLASTIC (82868-092-28) | November 6, 2025 |
| 66267-196-06 | 66267-196 | NuCare Pharmaceuticals, Inc. | 6 TABLET in 1 BOTTLE (66267-196-06) | October 14, 2016 |
| 66267-196-10 | 66267-196 | NuCare Pharmaceuticals, Inc. | 10 TABLET in 1 BOTTLE (66267-196-10) | October 14, 2016 |
| 66267-196-14 | 66267-196 | NuCare Pharmaceuticals, Inc. | 14 TABLET in 1 BOTTLE (66267-196-14) | October 14, 2016 |
| 66267-196-20 | 66267-196 | NuCare Pharmaceuticals, Inc. | 20 TABLET in 1 BOTTLE (66267-196-20) | October 14, 2016 |
| 66267-196-28 | 66267-196 | NuCare Pharmaceuticals, Inc. | 28 TABLET in 1 BOTTLE (66267-196-28) | October 14, 2016 |
| 66267-196-30 | 66267-196 | NuCare Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE (66267-196-30) | October 14, 2016 |
| 66267-196-60 | 66267-196 | NuCare Pharmaceuticals, Inc. | 60 TABLET in 1 BOTTLE (66267-196-60) | October 14, 2016 |
| 66267-196-90 | 66267-196 | NuCare Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE (66267-196-90) | October 14, 2016 |
| 66267-816-02 | 66267-816 | NuCare Pharmaceuticals, Inc. | 2 TABLET in 1 BOTTLE (66267-816-02) | January 24, 2017 |
| 66267-816-04 | 66267-816 | NuCare Pharmaceuticals, Inc. | 4 TABLET in 1 BOTTLE (66267-816-04) | January 24, 2017 |
| 66267-816-06 | 66267-816 | NuCare Pharmaceuticals, Inc. | 6 TABLET in 1 BOTTLE (66267-816-06) | January 24, 2017 |
| 68071-3579-1 | 68071-3579 | NuCare Pharmaceuticals,Inc. | 100 TABLET in 1 BOTTLE (68071-3579-1) | February 28, 2024 |
| 68071-4710-1 | 68071-4710 | NuCare Pharmaceuticals,Inc. | 10 TABLET in 1 BOTTLE (68071-4710-1) | January 15, 2019 |
| 68071-4710-2 | 68071-4710 | NuCare Pharmaceuticals,Inc. | 20 TABLET in 1 BOTTLE (68071-4710-2) | January 15, 2019 |
| 68071-4710-3 | 68071-4710 | NuCare Pharmaceuticals,Inc. | 30 TABLET in 1 BOTTLE (68071-4710-3) | January 15, 2019 |
| 68071-4710-4 | 68071-4710 | NuCare Pharmaceuticals,Inc. | 14 TABLET in 1 BOTTLE (68071-4710-4) | January 15, 2019 |
| 68071-4710-5 | 68071-4710 | NuCare Pharmaceuticals,Inc. | 15 TABLET in 1 BOTTLE (68071-4710-5) | January 15, 2019 |
| 68071-4710-6 | 68071-4710 | NuCare Pharmaceuticals,Inc. | 6 TABLET in 1 BOTTLE (68071-4710-6) | January 15, 2019 |
| 68071-4710-8 | 68071-4710 | NuCare Pharmaceuticals,Inc. | 28 TABLET in 1 BOTTLE (68071-4710-8) | January 15, 2019 |
| 68071-4948-2 | 68071-4948 | NuCare Pharmaceuticals,Inc. | 2 TABLET in 1 BOTTLE (68071-4948-2) | June 26, 2019 |
| 68071-4948-4 | 68071-4948 | NuCare Pharmaceuticals,Inc. | 4 TABLET in 1 BOTTLE (68071-4948-4) | June 26, 2019 |
| 68071-4948-6 | 68071-4948 | NuCare Pharmaceuticals,Inc. | 6 TABLET in 1 BOTTLE (68071-4948-6) | January 5, 2026 |
| 72789-018-02 | 72789-018 | PD-Rx Pharmaceuticals, Inc. | 2 TABLET in 1 BOTTLE, PLASTIC (72789-018-02) | April 10, 2020 |
| 72789-018-04 | 72789-018 | PD-Rx Pharmaceuticals, Inc. | 4 TABLET in 1 BOTTLE, PLASTIC (72789-018-04) | February 26, 2020 |
| 72789-018-06 | 72789-018 | PD-Rx Pharmaceuticals, Inc. | 6 TABLET in 1 BOTTLE, PLASTIC (72789-018-06) | October 17, 2019 |
| 72789-018-10 | 72789-018 | PD-Rx Pharmaceuticals, Inc. | 10 TABLET in 1 BOTTLE, PLASTIC (72789-018-10) | October 29, 2019 |
| 72789-018-14 | 72789-018 | PD-Rx Pharmaceuticals, Inc. | 14 TABLET in 1 BOTTLE, PLASTIC (72789-018-14) | November 1, 2019 |
| 72789-018-20 | 72789-018 | PD-Rx Pharmaceuticals, Inc. | 20 TABLET in 1 BOTTLE, PLASTIC (72789-018-20) | October 17, 2019 |
| 72789-018-28 | 72789-018 | PD-Rx Pharmaceuticals, Inc. | 28 TABLET in 1 BOTTLE, PLASTIC (72789-018-28) | February 13, 2020 |
| 72789-018-40 | 72789-018 | PD-Rx Pharmaceuticals, Inc. | 40 TABLET in 1 BOTTLE, PLASTIC (72789-018-40) | November 22, 2019 |
| 72789-018-60 | 72789-018 | PD-Rx Pharmaceuticals, Inc. | 60 TABLET in 1 BOTTLE, PLASTIC (72789-018-60) | October 17, 2019 |
| 72789-064-06 | 72789-064 | PD-Rx Pharmaceuticals, Inc. | 6 TABLET in 1 BOTTLE, PLASTIC (72789-064-06) | March 23, 2020 |
| 72789-064-14 | 72789-064 | PD-Rx Pharmaceuticals, Inc. | 14 TABLET in 1 BOTTLE, PLASTIC (72789-064-14) | July 3, 2024 |
| 72789-064-20 | 72789-064 | PD-Rx Pharmaceuticals, Inc. | 20 TABLET in 1 BOTTLE, PLASTIC (72789-064-20) | March 23, 2020 |
| 82982-044-14 | 82982-044 | Pharmasource Meds, LLC | 14 TABLET in 1 BOTTLE (82982-044-14) | February 28, 2023 |
| 82982-044-20 | 82982-044 | Pharmasource Meds, LLC | 20 TABLET in 1 BOTTLE (82982-044-20) | February 28, 2023 |
| 68788-7622-1 | 68788-7622 | Preferred Pharmaceuticals Inc. | 10 TABLET in 1 BOTTLE (68788-7622-1) | February 14, 2020 |
| 68788-7622-2 | 68788-7622 | Preferred Pharmaceuticals Inc. | 20 TABLET in 1 BOTTLE (68788-7622-2) | February 14, 2020 |
| 68788-7622-3 | 68788-7622 | Preferred Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (68788-7622-3) | February 14, 2020 |
| 68788-7622-4 | 68788-7622 | Preferred Pharmaceuticals Inc. | 14 TABLET in 1 BOTTLE (68788-7622-4) | February 14, 2020 |
| 68788-7622-6 | 68788-7622 | Preferred Pharmaceuticals Inc. | 6 TABLET in 1 BOTTLE (68788-7622-6) | February 14, 2020 |
| 68788-7622-7 | 68788-7622 | Preferred Pharmaceuticals Inc. | 28 TABLET in 1 BOTTLE (68788-7622-7) | February 14, 2020 |
| 68788-7622-8 | 68788-7622 | Preferred Pharmaceuticals Inc. | 40 TABLET in 1 BOTTLE (68788-7622-8) | February 14, 2020 |
| 63187-008-06 | 63187-008 | Proficient Rx LP | 6 TABLET in 1 BOTTLE (63187-008-06) | November 1, 2018 |
| 63187-008-10 | 63187-008 | Proficient Rx LP | 10 TABLET in 1 BOTTLE (63187-008-10) | November 1, 2018 |
| 63187-008-14 | 63187-008 | Proficient Rx LP | 14 TABLET in 1 BOTTLE (63187-008-14) | November 1, 2018 |
| 63187-008-20 | 63187-008 | Proficient Rx LP | 20 TABLET in 1 BOTTLE (63187-008-20) | November 1, 2018 |
| 63187-008-28 | 63187-008 | Proficient Rx LP | 28 TABLET in 1 BOTTLE (63187-008-28) | November 1, 2018 |
| 63187-008-40 | 63187-008 | Proficient Rx LP | 40 TABLET in 1 BOTTLE (63187-008-40) | November 1, 2018 |
| 63187-695-06 | 63187-695 | Proficient Rx LP | 6 TABLET in 1 BOTTLE (63187-695-06) | December 1, 2016 |
| 63187-695-10 | 63187-695 | Proficient Rx LP | 10 TABLET in 1 BOTTLE (63187-695-10) | December 1, 2016 |
| 63187-695-14 | 63187-695 | Proficient Rx LP | 14 TABLET in 1 BOTTLE (63187-695-14) | December 1, 2016 |
| 63187-695-20 | 63187-695 | Proficient Rx LP | 20 TABLET in 1 BOTTLE (63187-695-20) | December 1, 2016 |
| 63187-695-28 | 63187-695 | Proficient Rx LP | 28 TABLET in 1 BOTTLE (63187-695-28) | December 1, 2016 |
| 63187-695-40 | 63187-695 | Proficient Rx LP | 40 TABLET in 1 BOTTLE (63187-695-40) | December 1, 2016 |
| 63187-782-06 | 63187-782 | Proficient Rx LP | 6 TABLET in 1 BOTTLE (63187-782-06) | November 1, 2016 |
| 63187-782-10 | 63187-782 | Proficient Rx LP | 10 TABLET in 1 BOTTLE (63187-782-10) | November 1, 2016 |
| 63187-782-14 | 63187-782 | Proficient Rx LP | 14 TABLET in 1 BOTTLE (63187-782-14) | November 1, 2016 |
| 63187-782-20 | 63187-782 | Proficient Rx LP | 20 TABLET in 1 BOTTLE (63187-782-20) | November 1, 2016 |
| 63187-782-28 | 63187-782 | Proficient Rx LP | 28 TABLET in 1 BOTTLE (63187-782-28) | November 1, 2016 |
| 63187-782-40 | 63187-782 | Proficient Rx LP | 40 TABLET in 1 BOTTLE (63187-782-40) | November 1, 2016 |
| 71205-810-06 | 71205-810 | Proficient Rx LP | 6 TABLET in 1 BOTTLE (71205-810-06) | July 19, 2023 |
| 71205-810-10 | 71205-810 | Proficient Rx LP | 10 TABLET in 1 BOTTLE (71205-810-10) | May 31, 2023 |
| 71205-810-14 | 71205-810 | Proficient Rx LP | 14 TABLET in 1 BOTTLE (71205-810-14) | May 31, 2023 |
| 71205-810-20 | 71205-810 | Proficient Rx LP | 20 TABLET in 1 BOTTLE (71205-810-20) | June 2, 2023 |
| 71205-810-28 | 71205-810 | Proficient Rx LP | 28 TABLET in 1 BOTTLE (71205-810-28) | June 2, 2023 |
| 71205-810-30 | 71205-810 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (71205-810-30) | May 31, 2023 |
| 71205-810-40 | 71205-810 | Proficient Rx LP | 40 TABLET in 1 BOTTLE (71205-810-40) | August 21, 2023 |
| 71205-810-60 | 71205-810 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (71205-810-60) | May 31, 2023 |
| 71205-810-90 | 71205-810 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (71205-810-90) | May 31, 2023 |
| 42708-053-20 | 42708-053 | QPharma, Inc. | 20 TABLET in 1 BOTTLE (42708-053-20) | March 14, 2018 |
| 55700-611-20 | 55700-611 | Quality Care Products LLC | 20 TABLET in 1 BOTTLE (55700-611-20) | May 4, 2018 |
| 70518-0863-5 | 70518-0863 | REMEDYREPACK INC. | 14 TABLET in 1 BOTTLE, PLASTIC (70518-0863-5) | April 11, 2023 |
| 70518-0863-6 | 70518-0863 | REMEDYREPACK INC. | 30 TABLET in 1 BLISTER PACK (70518-0863-6) | June 25, 2025 |
| 70518-2604-2 | 70518-2604 | REMEDYREPACK INC. | 6 TABLET in 1 BOTTLE, PLASTIC (70518-2604-2) | March 1, 2021 |
| 70518-2604-3 | 70518-2604 | REMEDYREPACK INC. | 14 TABLET in 1 BLISTER PACK (70518-2604-3) | March 7, 2022 |
| 70518-2604-4 | 70518-2604 | REMEDYREPACK INC. | 20 TABLET in 1 BOTTLE, PLASTIC (70518-2604-4) | March 11, 2022 |
| 70518-2604-5 | 70518-2604 | REMEDYREPACK INC. | 30 TABLET in 1 BLISTER PACK (70518-2604-5) | March 17, 2022 |
| 70518-2604-6 | 70518-2604 | REMEDYREPACK INC. | 20 TABLET in 1 BLISTER PACK (70518-2604-6) | April 12, 2022 |
| 70518-2604-8 | 70518-2604 | REMEDYREPACK INC. | 14 TABLET in 1 BOTTLE, PLASTIC (70518-2604-8) | May 27, 2022 |
| 70518-2604-9 | 70518-2604 | REMEDYREPACK INC. | 10 TABLET in 1 BOTTLE, PLASTIC (70518-2604-9) | June 7, 2022 |
| 70518-3432-1 | 70518-3432 | REMEDYREPACK INC. | 100 POUCH in 1 BOX (70518-3432-1) / 1 TABLET in 1 POUCH (70518-3432-2) | January 4, 2023 |
| 70518-3432-3 | 70518-3432 | REMEDYREPACK INC. | 6 TABLET in 1 BOTTLE, PLASTIC (70518-3432-3) | February 16, 2023 |
| 70518-3432-4 | 70518-3432 | REMEDYREPACK INC. | 28 TABLET in 1 BOTTLE, PLASTIC (70518-3432-4) | December 23, 2023 |
| 70518-3432-5 | 70518-3432 | REMEDYREPACK INC. | 30 TABLET in 1 BOTTLE, PLASTIC (70518-3432-5) | April 29, 2024 |
| 70518-3454-3 | 70518-3454 | REMEDYREPACK INC. | 20 TABLET in 1 BOTTLE, PLASTIC (70518-3454-3) | July 1, 2025 |
| 70518-3454-4 | 70518-3454 | REMEDYREPACK INC. | 10 TABLET in 1 BOTTLE, PLASTIC (70518-3454-4) | August 6, 2025 |
| 57237-232-01 | 57237-232 | Rising Pharma Holdings, Inc. | 100 TABLET in 1 BOTTLE (57237-232-01) | February 16, 2010 |
| 57237-232-05 | 57237-232 | Rising Pharma Holdings, Inc. | 500 TABLET in 1 BOTTLE (57237-232-05) | February 16, 2010 |
| 57237-233-01 | 57237-233 | Rising Pharma Holdings, Inc. | 100 TABLET in 1 BOTTLE (57237-233-01) | February 16, 2010 |
| 57237-233-05 | 57237-233 | Rising Pharma Holdings, Inc. | 500 TABLET in 1 BOTTLE (57237-233-05) | February 16, 2010 |
| 85766-015-01 | 85766-015 | Sportpharm LLC | 100 TABLET in 1 BOTTLE (85766-015-01) | June 20, 2025 |
| 85766-015-05 | 85766-015 | Sportpharm LLC | 500 TABLET in 1 BOTTLE (85766-015-05) | June 20, 2025 |
| 85766-015-06 | 85766-015 | Sportpharm LLC | 6 TABLET in 1 BOTTLE (85766-015-06) | June 20, 2025 |
| 85766-015-10 | 85766-015 | Sportpharm LLC | 10 TABLET in 1 BOTTLE (85766-015-10) | June 20, 2025 |
| 85766-015-14 | 85766-015 | Sportpharm LLC | 14 TABLET in 1 BOTTLE (85766-015-14) | June 20, 2025 |
| 85766-015-20 | 85766-015 | Sportpharm LLC | 20 TABLET in 1 BOTTLE (85766-015-20) | June 20, 2025 |
| 85766-015-28 | 85766-015 | Sportpharm LLC | 28 TABLET in 1 BOTTLE (85766-015-28) | June 20, 2025 |
| 85766-015-30 | 85766-015 | Sportpharm LLC | 30 TABLET in 1 BOTTLE (85766-015-30) | June 20, 2025 |
| 60760-541-06 | 60760-541 | St. Mary's Medical Park Pharmacy | 6 TABLET in 1 BOTTLE, PLASTIC (60760-541-06) | January 17, 2023 |
| 60760-541-14 | 60760-541 | St. Mary's Medical Park Pharmacy | 14 TABLET in 1 BOTTLE, PLASTIC (60760-541-14) | August 18, 2022 |
| 60760-541-20 | 60760-541 | St. Mary's Medical Park Pharmacy | 20 TABLET in 1 BOTTLE, PLASTIC (60760-541-20) | June 22, 2022 |
| 53489-145-01 | 53489-145 | Sun Pharmaceutical Industries, Inc. | 100 TABLET in 1 BOTTLE, PLASTIC (53489-145-01) | August 25, 1986 |
| 53489-145-05 | 53489-145 | Sun Pharmaceutical Industries, Inc. | 500 TABLET in 1 BOTTLE, PLASTIC (53489-145-05) | August 25, 1986 |
| 53489-146-01 | 53489-146 | Sun Pharmaceutical Industries, Inc. | 100 TABLET in 1 BOTTLE, PLASTIC (53489-146-01) | August 25, 1986 |
| 53489-146-05 | 53489-146 | Sun Pharmaceutical Industries, Inc. | 500 TABLET in 1 BOTTLE, PLASTIC (53489-146-05) | August 25, 1986 |
| 87441-078-01 | 87441-078 | Unit Dose Solutions, Inc. | 30 TABLET in 1 BLISTER PACK (87441-078-01) | July 9, 2026 |
| 83939-0023-1 | 83939-0023 | VERITYRX, LLC | 1 TABLET in 1 POUCH (83939-0023-1) | November 3, 2025 |
| 83939-0023-2 | 83939-0023 | VERITYRX, LLC | 50 BOX, UNIT-DOSE in 1 BOX, UNIT-DOSE (83939-0023-2) / 1 TABLET in 1 BOX, UNIT-DOSE | November 3, 2025 |
| 83939-0023-3 | 83939-0023 | VERITYRX, LLC | 100 POUCH in 1 BOX, UNIT-DOSE (83939-0023-3) / 1 TABLET in 1 POUCH | November 3, 2025 |
| 61971-115-01 | 61971-115 | Vista Pharmaceuticals, Inc. | 100 TABLET in 1 BOTTLE (61971-115-01) | June 6, 2006 |
| 61971-115-05 | 61971-115 | Vista Pharmaceuticals, Inc. | 500 TABLET in 1 BOTTLE (61971-115-05) | June 6, 2006 |
| 61971-120-01 | 61971-120 | Vista Pharmaceuticals, Inc. | 100 TABLET in 1 BOTTLE (61971-120-01) | August 22, 2006 |
| 61971-120-05 | 61971-120 | Vista Pharmaceuticals, Inc. | 500 TABLET in 1 BOTTLE (61971-120-05) | August 22, 2006 |
| 50090-2198 | 50090-2198 | A-S Medication Solutions | — | February 16, 2010 |
| 50090-2199 | 50090-2199 | A-S Medication Solutions | — | February 16, 2010 |
| 50090-2200 | 50090-2200 | A-S Medication Solutions | — | February 16, 2010 |
| 50090-2201 | 50090-2201 | A-S Medication Solutions | — | February 16, 2010 |
| 50090-2479 | 50090-2479 | A-S Medication Solutions | — | February 16, 2010 |
| 50090-4847 | 50090-4847 | A-S Medication Solutions | — | September 13, 2010 |
| 50090-4848 | 50090-4848 | A-S Medication Solutions | — | September 13, 2010 |
| 50090-4850 | 50090-4850 | A-S Medication Solutions | — | September 13, 2010 |
| 50090-5679 | 50090-5679 | A-S Medication Solutions | — | February 16, 2010 |
| 50090-5680 | 50090-5680 | A-S Medication Solutions | — | February 16, 2010 |
| 50090-5682 | 50090-5682 | A-S Medication Solutions | — | February 16, 2010 |
| 50090-6901 | 50090-6901 | A-S Medication Solutions | — | September 13, 2010 |
| 50090-6902 | 50090-6902 | A-S Medication Solutions | — | September 13, 2010 |
| 50090-6904 | 50090-6904 | A-S Medication Solutions | — | September 13, 2010 |
| 50090-7008 | 50090-7008 | A-S Medication Solutions | — | September 13, 2010 |
| 50090-7393 | 50090-7393 | A-S Medication Solutions | — | February 16, 2010 |
| 50090-7399 | 50090-7399 | A-S Medication Solutions | — | February 16, 2010 |
| 80425-0001 | 80425-0001 | Advanced Rx Pharmacy of Tennessee, LLC | — | September 13, 2010 |
| 80425-0002 | 80425-0002 | Advanced Rx Pharmacy of Tennessee, LLC | — | February 16, 2010 |
| 80425-0003 | 80425-0003 | Advanced Rx Pharmacy of Tennessee, LLC | — | February 16, 2010 |
| 60687-614 | 60687-614 | American Health Packaging | — | January 3, 2022 |
| 65162-271 | 65162-271 | Amneal Pharmaceuticals LLC | — | February 25, 2010 |
| 65162-272 | 65162-272 | Amneal Pharmaceuticals LLC | — | September 13, 2010 |
| 53746-271 | 53746-271 | Amneal Pharmaceuticals of New York LLC | — | February 25, 2010 |
| 53746-272 | 53746-272 | Amneal Pharmaceuticals of New York LLC | — | September 13, 2010 |
| 76420-064 | 76420-064 | Asclemed USA, Inc. | — | February 16, 2010 |
| 65862-419 | 65862-419 | Aurobindo Pharma Limited | — | February 16, 2010 |
| 65862-420 | 65862-420 | Aurobindo Pharma Limited | — | February 16, 2010 |
| 42291-758 | 42291-758 | AvKARE | — | August 5, 2015 |
| 42291-759 | 42291-759 | AvKARE | — | August 5, 2015 |
| 50268-728 | 50268-728 | AvPAK | — | September 23, 2014 |
| 63629-1765 | 63629-1765 | Bryant Ranch Prepack | — | September 13, 2010 |
| 71335-0762 | 71335-0762 | Bryant Ranch Prepack | — | February 16, 2010 |
| 55154-2580 | 55154-2580 | Cardinal Health 107, LLC | — | March 23, 2026 |
| 55154-7895 | 55154-7895 | Cardinal Health 107, LLC | — | September 13, 2010 |
| 62135-897 | 62135-897 | Chartwell RX, LLC | — | January 25, 2007 |
| 62135-898 | 62135-898 | Chartwell RX, LLC | — | January 25, 2007 |
| 67046-0295 | 67046-0295 | Coupler LLC | — | May 11, 2026 |
| 69043-010 | 69043-010 | Cronus Pharma LLC | — | February 16, 2010 |
| 69043-011 | 69043-011 | Cronus Pharma LLC | — | February 16, 2010 |
| 70934-544 | 70934-544 | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | — | February 12, 2020 |
| 60429-259 | 60429-259 | Golden State Medical Supply, Inc. | — | August 25, 1986 |
| 0904-2725 | 0904-2725 | Major Pharmaceuticals | — | September 13, 2010 |
| 0615-8121 | 0615-8121 | NCS HealthCare of KY, LLC dba Vangard Labs | — | February 16, 2010 |
| 51655-188 | 51655-188 | Northwind Health Company, LLC | — | March 23, 2023 |
| 51655-307 | 51655-307 | Northwind Health Company, LLC | — | November 17, 2022 |
| 82868-092 | 82868-092 | Northwind Health Company, LLC | — | November 6, 2025 |
| 66267-196 | 66267-196 | NuCare Pharmaceuticals, Inc. | — | February 16, 2010 |
| 66267-816 | 66267-816 | NuCare Pharmaceuticals, Inc. | — | February 16, 2010 |
| 68071-3579 | 68071-3579 | NuCare Pharmaceuticals,Inc. | — | February 16, 2010 |
| 68071-4710 | 68071-4710 | NuCare Pharmaceuticals,Inc. | — | February 16, 2010 |
| 68071-4948 | 68071-4948 | NuCare Pharmaceuticals,Inc. | — | February 16, 2010 |
| 72789-018 | 72789-018 | PD-Rx Pharmaceuticals, Inc. | — | February 16, 2010 |
| 72789-064 | 72789-064 | PD-Rx Pharmaceuticals, Inc. | — | February 16, 2010 |
| 82982-044 | 82982-044 | Pharmasource Meds, LLC | — | February 28, 2023 |
| 68788-7622 | 68788-7622 | Preferred Pharmaceuticals Inc. | — | February 14, 2020 |
| 63187-008 | 63187-008 | Proficient Rx LP | — | August 22, 2006 |
| 63187-695 | 63187-695 | Proficient Rx LP | — | February 16, 2010 |
| 63187-782 | 63187-782 | Proficient Rx LP | — | September 13, 2010 |
| 71205-810 | 71205-810 | Proficient Rx LP | — | February 16, 2010 |
| 42708-053 | 42708-053 | QPharma, Inc. | — | February 16, 2010 |
| 55700-611 | 55700-611 | Quality Care Products LLC | — | May 4, 2018 |
| 70518-0863 | 70518-0863 | REMEDYREPACK INC. | — | November 24, 2017 |
| 70518-2604 | 70518-2604 | REMEDYREPACK INC. | — | February 28, 2020 |
| 70518-3432 | 70518-3432 | REMEDYREPACK INC. | — | June 8, 2022 |
| 70518-3454 | 70518-3454 | REMEDYREPACK INC. | — | July 18, 2022 |
| 57237-232 | 57237-232 | Rising Pharma Holdings, Inc. | — | February 16, 2010 |
| 57237-233 | 57237-233 | Rising Pharma Holdings, Inc. | — | February 16, 2010 |
| 85766-015 | 85766-015 | Sportpharm LLC | — | February 16, 2010 |
| 60760-541 | 60760-541 | St. Mary's Medical Park Pharmacy | — | June 22, 2022 |
| 53489-145 | 53489-145 | Sun Pharmaceutical Industries, Inc. | — | August 25, 1986 |
| 53489-146 | 53489-146 | Sun Pharmaceutical Industries, Inc. | — | August 25, 1986 |
| 87441-078 | 87441-078 | Unit Dose Solutions, Inc. | — | July 9, 2026 |
| 83939-0023 | 83939-0023 | VERITYRX, LLC | — | February 16, 2010 |
| 61971-115 | 61971-115 | Vista Pharmaceuticals, Inc. | — | June 6, 2006 |
| 61971-120 | 61971-120 | Vista Pharmaceuticals, Inc. | — | August 22, 2006 |
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.