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Triamcinolone Acetonide
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 |
|---|---|---|---|---|---|---|---|
| 207550-001 | TRIAMCINOLONE ACETONIDE | INJECTABLE | TRIAMCINOLONE ACETONIDE | 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 | 3 | Labeling | Approved | October 3, 2019 | Standard |
| Original application | 1 | Approved | December 11, 2017 | Standard |
Review documents
- 0 · Original application · January 8, 2018
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260814). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingINDICATIONS AND USAGE Intramuscular Where oral therapy is not feasible, injectable corticosteroid therapy, including triamcinolone acetonide injectable suspension, USP is indicated for intramuscular use as follows: Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. Intra-Articular The intra-articular or soft tissue administration of triamcinolone acetonide injectable suspension is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.
Dosage and Administration
openFDA Drug LabelingDOSAGE AND ADMINISTRATION General NOTE: CONTAINS BENZYL ALCOHOL (see PRECAUTIONS ). The initial dose of triamcinolone acetonide injectable suspension may vary from 2.5 mg to 100 mg per day depending on the specific disease entity being treated (see Dosage section below). However, in certain overwhelming, acute, life-threatening situations, administration in dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages. 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 decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. 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 exposure 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 the corticosteroid 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. Dosage SYSTEMIC The suggested initial dose is 60 mg, injected deeply into the gluteal muscle . Atrophy of subcutaneous fat may occur if the injection is not properly given. Dosage is usually adjusted within the range of 40 mg to 80 mg, depending upon patient response and duration of relief. However, some patients may be well controlled on doses as low as 20 mg or less. Hay fever or pollen asthma: Patients with hay fever or pollen asthma who are not responding to pollen administration and other conventional therapy may obtain a remission of symptoms lasting throughout the pollen season after a single injection of 40 mg to 100 mg. In the treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of triamcinolone for a week followed by 64 mg every other day for one month are recommended (see PRECAUTIONS : Neuro-Psychiatric ). In pediatric patients, the initial dose of triamcinolone may vary depending on the specific disease entity being treated. The range of initial doses is 0.11 mg/kg/day to 1.6 mg/kg/day in 3 or 4 divided doses (3.2 mg/m 2 bsa/day to 48 mg/m 2 bsa/day). For the purpose of comparison, the following is the equivalent milligram dosage of the various glucocorticoids: Cortisone, 25 Triamcinolone, 4 Hydrocortisone, 20 Paramethasone, 2 Prednisolone, 5 Betamethasone, 0.75 Prednisone, 5 Dexamethasone, 0.75 Methylprednisolone, 4 These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered. LOCAL Intra-articular administration: A single local injection of triamcinolone acetonide is frequently sufficient, but several injections may be needed for adequate relief of symptoms. Initial dose: 2.5 mg to 5 mg for smaller joints and from 5 mg to 15 mg for larger joints, depending on the specific disease entity being treated. For adults, doses up to 10 mg for smaller areas and up to 40 mg for larger areas have usually been sufficient. Single injections into several joints, up to a total of 80 mg, have been given. Administration GENERAL STRICT ASEPTIC TECHNIQUE IS MANDATORY. The vial should be shaken before use to ensure a uniform suspension. Prior to withdrawal, the suspension should be inspected for clumping or granular appearance (agglomeration). Agglomeration occurs when the drug substance separates from the solution and appears as a white precipitate in the vial. An agglomerated product …
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS Triamcinolone acetonide injectable suspension is contraindicated in patients who are hypersensitive to any components of this product (see WARNINGS : General ). Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.
Warnings and Cautions
openFDA Drug LabelingSerious Neurologic Adverse Reactions with Epidural Administration Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids (see WARNINGS: NEUROLOGIC). Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been reported with and without use of fluoroscopy. The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use. General Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. There have been rare reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol. The amount of benzyl alcohol from medications is usually considered negligible compared to that received in flush solutions containing benzyl alcohol. Administration of high dosages of medications containing this preservative must take into account the total amount of benzyl alcohol administered. The amount of benzyl alcohol at which toxicity may occur is not known. If the patient requires more than the recommended dosages or other medications containing this preservative, the practitioner must consider the daily metabolic load of benzyl alcohol from these combined sources (see PRECAUTIONS: PEDIATRIC USE). Rare instances of anaphylaxis have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS). Cases of serious anaphylaxis, including death, have been reported in individuals receiving triamcinolone acetonide injection, regardless of the route of administration. Because triamcinolone acetonide injectable suspension is a suspension, it should not be administered intravenously. Unless a deep intramuscular injection is given, local atrophy is likely to occur. (For recommendations on injection techniques, see DOSAGE AND ADMINISTRATION.) Due to the significantly higher incidence of local atrophy when the material is injected into the deltoid area, this injection site should be avoided in favor of the gluteal area. 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. Triamcinolone acetonide injectable suspension is a long-acting preparation, and is not suitable for use in acute stress situations. To avoid drug-induced adrenal insufficiency, supportive dosage may be required in times of stress (such as trauma, surgery, or severe illness) both during treatment with triamcinolone acetonide injectable suspension and for a year afterwards. Results from one multicenter, randomized, placebo-controlled study with methylprednisolone hemisuccinate, an intravenous corticosteroid, showed an increase in early (at 2 weeks) and late (at 6 months) mortality in patients with cranial trauma who were determined not to have other clear indications for corticosteroid treatment. High doses of systemic corticosteroids, including triamcinolone acetonide injectable suspension, should not be used for the treatment of traumatic brain injury. Cardio-Renal Average and large doses of corticosteroids 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 they are used in large doses. Dietary salt restriction and potassium supplementation may be necessary (see PRECAUTIONS). 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 cauti …
Warnings
openFDA Drug LabelingWARNINGS Serious Neurologic Adverse Reactions with Epidural Administration Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids (see WARNINGS: Neurologic ). Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been reported with and without use of fluoroscopy. The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use. General Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. There have been rare reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol. The amount of benzyl alcohol from medications is usually considered negligible compared to that received in flush solutions containing benzyl alcohol. Administration of high dosages of medications containing this preservative must take into account the total amount of benzyl alcohol administered. The amount of benzyl alcohol at which toxicity may occur is not known. If the patient requires more than the recommended dosages or other medications containing this preservative, the practitioner must consider the daily metabolic load of benzyl alcohol from these combined sources (see PRECAUTIONS: Pediatric Use ). Rare instances of anaphylaxis have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS ). Cases of serious anaphylaxis, including death, have been reported in individuals receiving triamcinolone acetonide injection, regardless of the route of administration. Because triamcinolone acetonide injectable suspension is a suspension, it should not be administered intravenously. Unless a deep intramuscular injection is given, local atrophy is likely to occur (for recommendations on injection techniques, see DOSAGE AND ADMINISTRATION ). Due to the significantly higher incidence of local atrophy when the material is injected into the deltoid area, this injection site should be avoided in favor of the gluteal area. 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. Triamcinolone acetonide injectable suspension is a long-acting preparation, and is not suitable for use in acute stress situations. To avoid drug-induced adrenal insufficiency, supportive dosage may be required in times of stress (such as trauma, surgery, or severe illness) both during treatment with triamcinolone acetonide injectable suspension and for a year afterwards. Results from one multicenter, randomized, placebo-controlled study with methylprednisolone hemisuccinate, an intravenous corticosteroid, showed an increase in early (at 2 weeks) and late (at 6 months) mortality in patients with cranial trauma who were determined not to have other clear indications for corticosteroid treatment. High doses of systemic corticosteroids, including triamcinolone acetonide injectable suspension should not be used for the treatment of traumatic brain injury. Cardio-Renal Average and large doses of corticosteroids 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 they are used in large doses. Dietary salt restriction and potassium supplementation may be necessary (see PRECAUTIONS ). 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 …
Adverse Reactions
openFDA Drug LabelingADVERSE REACTIONS (listed alphabetically under each subsection) The following adverse reactions may be associated with corticosteroid therapy: Allergic reactions: Anaphylaxis including death, and angioedema. Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS ), pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis. Dermatologic: Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, lupus erythematosus-like lesions, purpura, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria. Endocrine: Decreased carbohydrate and glucose tolerance, development of cushingoid state, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents in diabetes, manifestations of latent diabetes mellitus, menstrual irregularities, postmenopausal vaginal hemorrhage, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), suppression of growth in pediatric patients. Fluid and electrolyte disturbances: Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention. Gastrointestinal : Abdominal distention, bowel/bladder dysfunction (after intrathecal administration [see WARNINGS : Neurologic ]), elevation in serum liver enzyme levels (usually reversible upon discontinuation), hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis. Metabolic: Negative nitrogen balance due to protein catabolism. Musculoskeletal: Aseptic necrosis of femoral and humeral heads, calcinosis (following intra-articular or intralesional use), Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, post injection flare (following intra-articular use), steroid myopathy, tendon rupture, vertebral compression fractures. Neurologic/Psychiatric: Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychiatric disorders, vertigo. Arachnoiditis, meningitis, paraparesis/paraplegia, and sensory disturbances have occurred after intrathecal administration. Spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke (including brainstem) have been reported after epidural administration of corticosteroids (see WARNINGS: Serious Neurologic Adverse Reactions with Epidural Administration and WARNINGS: Neurologic ). Ophthalmic: Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, rare instances of blindness associated with periocular injections. Other: Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, weight gain. To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy's Laboratories Inc., at 1-888-375-3784, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
openFDA Drug LabelingDrug Interactions Aminoglutethimide: Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression. Amphotericin B injection and potassium-depleting agents: When corticosteroids are administered concomitantly with potassium-depleting agents ( i.e., amphotericin B, diuretics), patients should be observed closely for development of hypokalemia. 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. Anticholinesterases: Concomitant use of anticholinesterase agents 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. Anticoagulants, oral: Coadministration 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. 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. CYP 3A4 inhibitors: Triamcinolone acetonide is a substrate of CYP3A4. Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to an increased risk of corticosteroid side effects. Co-administration of other strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin, cobicistat-containing products) with triamcinolone acetonide injectable suspension may cause increased plasma concentration of triamcinolone leading to adverse reactions. (See ADVERSE REACTIONS .) During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving triamcinolone acetonide and strong CYP3A4 inhibitors (e.g., ritonavir). (See WARNINGS, Endocrine and PRECAUTIONS, Endocrine .) Consider the benefit-risk of concomitant use and monitor for systemic corticosteroid side effects. 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. Hepatic enzyme inducers (e.g., barbiturates, phenytoin, carbamazepine, rifampin ): Drugs which induce hepatic microsomal drug metabolizing enzyme activity may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Nonsteroidal anti-inflammatory drugs (NSAIDs): Concomitant use of aspirin (or other nonsteroidal anti-inflammatory drugs) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids. Skin tests: Corticosteroids may suppress reactions to skin tests. Vaccines: Patients on prolonged corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS: I …
Description
openFDA Drug LabelingDESCRIPTION Triamcinolone acetonide injectable suspension, USP is triamcinolone acetonide, a synthetic glucocorticoid corticosteroid with marked anti-inflammatory action, in a sterile aqueous suspension suitable for intralesional and intra-articular injection. THIS FORMULATION IS SUITABLE FOR INTRA-ARTICULAR AND INTRALESIONAL USE ONLY. Each mL of the sterile aqueous suspension provides 10 mg triamcinolone acetonide, with 0.66% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.63% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may have been added to adjust pH between 5.0 and 7.5. At the time of manufacture, the air in the container is replaced by nitrogen. The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is: Molecular formula: C 24 H 31 FO 6 Molecular weight: 434.51 g/mol Triamcinolone acetonide, USP is a white or almost white crystalline powder, and is practically insoluble in water and sparingly soluble in alcohol. structure
Overdosage
openFDA Drug LabelingOVERDOSAGE Treatment of acute overdosage is by supportive and symptomatic therapy. For chronic overdosage in the face of severe disease requiring continuous steroid therapy, the dosage of the corticosteroid may be reduced only temporarily, or alternate day treatment may be introduced.
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Triamcinolone acetonide injectable suspension, USP is a white to off white aqueous suspension, free from foreign particulate matter supplied in vials providing 40 mg triamcinolone acetonide per mL. NDC Triamcinolone Acetonide Injectable Package Factor Suspension, USP (40 mg per mL) 25021-054-01 1 mL Single-Dose Vial 25 vials per carton Discard unused portion of single-dose vial. NDC Triamcinolone Acetonide Injectable Package Factor Suspension, USP (40 mg per mL) 25021-054-05 200 mg per 5 mL Multi-Dose Vial 1 vial per carton NDC Triamcinolone Acetonide Injectable Package Factor Suspension, USP (40 mg per mL) 25021-054-10 400 mg per 10 mL Multi-Dose Vial 1 vial per carton Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Protect from temperatures below 20°C (68°F). Store vial in carton to protect from light. Do not refrigerate. Store vial upright. Once in use: Chemical and physical in-use stability has been demonstrated for 28 days below 25°C (77°F). From a microbiological point of view, once opened, the product may be stored for a maximum of 28 days at 15° to 25°C (59° to 77°F). Other in-use storage times and conditions are the responsibility of the user. Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex. sagent ® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60173 (USA) Made in India ©2025 Sagent Pharmaceuticals October 2025
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: TRIAMCINOLONE ACETONIDE. 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 | October 11, 2023 | Eugia US LLC | Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial. | Ongoing |
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 76420-016-10 | 76420-016 | ASCLEMED USA INC. | 1 VIAL in 1 CARTON (76420-016-10) / 10 mL in 1 VIAL | June 20, 2025 |
| 87063-077-05 | 87063-077 | ASCLEMED USA INC. | 1 VIAL in 1 CARTON (87063-077-05) / 5 mL in 1 VIAL | January 20, 2026 |
| 80425-0262-1 | 80425-0262 | Advanced Rx Pharmacy of Tennessee, LLC | 1 VIAL, MULTI-DOSE in 1 CARTON (80425-0262-1) / 5 mL in 1 VIAL, MULTI-DOSE | February 15, 2023 |
| 62332-090-05 | 62332-090 | Alembic Pharmaceuticals Inc. | 1 VIAL, MULTI-DOSE in 1 CARTON (62332-090-05) / 5 mL in 1 VIAL, MULTI-DOSE | October 17, 2025 |
| 62332-091-10 | 62332-091 | Alembic Pharmaceuticals Inc. | 1 VIAL, MULTI-DOSE in 1 CARTON (62332-091-10) / 10 mL in 1 VIAL, MULTI-DOSE | October 17, 2025 |
| 62332-812-01 | 62332-812 | Alembic Pharmaceuticals Inc. | 1 VIAL, SINGLE-DOSE in 1 CARTON (62332-812-01) / 1 mL in 1 VIAL, SINGLE-DOSE | October 17, 2025 |
| 62332-812-25 | 62332-812 | Alembic Pharmaceuticals Inc. | 25 VIAL, SINGLE-DOSE in 1 CARTON (62332-812-25) / 1 mL in 1 VIAL, SINGLE-DOSE | October 17, 2025 |
| 46708-090-05 | 46708-090 | Alembic Pharmaceuticals Limited | 1 VIAL, MULTI-DOSE in 1 CARTON (46708-090-05) / 5 mL in 1 VIAL, MULTI-DOSE | October 17, 2025 |
| 46708-091-10 | 46708-091 | Alembic Pharmaceuticals Limited | 1 VIAL, MULTI-DOSE in 1 CARTON (46708-091-10) / 10 mL in 1 VIAL, MULTI-DOSE | October 17, 2025 |
| 46708-812-01 | 46708-812 | Alembic Pharmaceuticals Limited | 1 VIAL, SINGLE-DOSE in 1 CARTON (46708-812-01) / 1 mL in 1 VIAL, SINGLE-DOSE | October 17, 2025 |
| 46708-812-25 | 46708-812 | Alembic Pharmaceuticals Limited | 25 VIAL, SINGLE-DOSE in 1 CARTON (46708-812-25) / 1 mL in 1 VIAL, SINGLE-DOSE | October 17, 2025 |
| 70121-1049-2 | 70121-1049 | Amneal Pharmaceuticals LLC | 1 VIAL in 1 CARTON (70121-1049-2) / 1 mL in 1 VIAL (70121-1049-1) | December 11, 2017 |
| 70121-1049-5 | 70121-1049 | Amneal Pharmaceuticals LLC | 25 VIAL in 1 CARTON (70121-1049-5) / 1 mL in 1 VIAL (70121-1049-1) | December 11, 2017 |
| 70121-1168-1 | 70121-1168 | Amneal Pharmaceuticals LLC | 1 VIAL, MULTI-DOSE in 1 CARTON (70121-1168-1) / 5 mL in 1 VIAL, MULTI-DOSE | December 11, 2017 |
| 70121-1169-1 | 70121-1169 | Amneal Pharmaceuticals LLC | 1 VIAL, MULTI-DOSE in 1 CARTON (70121-1169-1) / 10 mL in 1 VIAL, MULTI-DOSE | December 11, 2017 |
| 70121-1651-1 | 70121-1651 | Amneal Pharmaceuticals LLC | 1 VIAL in 1 CARTON (70121-1651-1) / 1 mL in 1 VIAL | December 11, 2017 |
| 70121-1651-5 | 70121-1651 | Amneal Pharmaceuticals LLC | 25 VIAL in 1 CARTON (70121-1651-5) / 1 mL in 1 VIAL | December 11, 2017 |
| 70121-1652-1 | 70121-1652 | Amneal Pharmaceuticals LLC | 1 VIAL, MULTI-DOSE in 1 CARTON (70121-1652-1) / 5 mL in 1 VIAL, MULTI-DOSE | December 11, 2017 |
| 70121-1653-1 | 70121-1653 | Amneal Pharmaceuticals LLC | 1 VIAL, MULTI-DOSE in 1 CARTON (70121-1653-1) / 10 mL in 1 VIAL, MULTI-DOSE | December 11, 2017 |
| 70121-1654-1 | 70121-1654 | Amneal Pharmaceuticals LLC | 1 VIAL, MULTI-DOSE in 1 CARTON (70121-1654-1) / 5 mL in 1 VIAL, MULTI-DOSE | December 11, 2017 |
| 70121-1655-1 | 70121-1655 | Amneal Pharmaceuticals LLC | 1 VIAL, MULTI-DOSE in 1 CARTON (70121-1655-1) / 10 mL in 1 VIAL, MULTI-DOSE | December 11, 2017 |
| 70121-1657-1 | 70121-1657 | Amneal Pharmaceuticals LLC | 1 VIAL in 1 CARTON (70121-1657-1) / 1 mL in 1 VIAL | December 11, 2017 |
| 70121-1657-5 | 70121-1657 | Amneal Pharmaceuticals LLC | 25 VIAL in 1 CARTON (70121-1657-5) / 1 mL in 1 VIAL | December 11, 2017 |
| 43598-677-11 | 43598-677 | Dr. Reddy's Laboratories Inc | 1 VIAL, SINGLE-DOSE in 1 CARTON (43598-677-11) / 1 mL in 1 VIAL, SINGLE-DOSE | October 20, 2025 |
| 43598-677-25 | 43598-677 | Dr. Reddy's Laboratories Inc | 25 VIAL, SINGLE-DOSE in 1 CARTON (43598-677-25) / 1 mL in 1 VIAL, SINGLE-DOSE | October 20, 2025 |
| 43598-694-11 | 43598-694 | Dr. Reddy's Laboratories Inc | 1 VIAL, MULTI-DOSE in 1 CARTON (43598-694-11) / 5 mL in 1 VIAL, MULTI-DOSE | October 20, 2025 |
| 43598-695-11 | 43598-695 | Dr. Reddy's Laboratories Inc | 1 VIAL, MULTI-DOSE in 1 CARTON (43598-695-11) / 10 mL in 1 VIAL, MULTI-DOSE | October 20, 2025 |
| 43598-676-11 | 43598-676 | Dr. Reddy's Labortories Inc | 1 VIAL, MULTI-DOSE in 1 CARTON (43598-676-11) / 5 mL in 1 VIAL, MULTI-DOSE | August 4, 2025 |
| 55150-384-01 | 55150-384 | Eugia US LLC | 1 VIAL, MULTI-DOSE in 1 CARTON (55150-384-01) / 5 mL in 1 VIAL, MULTI-DOSE | July 5, 2022 |
| 55150-385-01 | 55150-385 | Eugia US LLC | 1 VIAL, MULTI-DOSE in 1 CARTON (55150-385-01) / 10 mL in 1 VIAL, MULTI-DOSE | July 5, 2022 |
| 0143-9387-25 | 0143-9387 | Hikma Pharmaceuticals USA Inc. | 25 VIAL in 1 CARTON (0143-9387-25) / 1 mL in 1 VIAL (0143-9387-01) | March 3, 2025 |
| 67457-621-99 | 67457-621 | Mylan Institutional LLC | 25 VIAL, SINGLE-DOSE in 1 CARTON (67457-621-99) / 1 mL in 1 VIAL, SINGLE-DOSE | August 19, 2024 |
| 67457-622-99 | 67457-622 | Mylan Institutional LLC | 25 VIAL, MULTI-DOSE in 1 CARTON (67457-622-99) / 5 mL in 1 VIAL, MULTI-DOSE | August 19, 2024 |
| 67457-623-99 | 67457-623 | Mylan Institutional LLC | 25 VIAL, MULTI-DOSE in 1 CARTON (67457-623-99) / 10 mL in 1 VIAL, MULTI-DOSE | August 19, 2024 |
| 16714-130-01 | 16714-130 | NorthStar Rx LLC | 1 VIAL in 1 CARTON (16714-130-01) / 1 mL in 1 VIAL | November 19, 2019 |
| 16714-130-25 | 16714-130 | NorthStar Rx LLC | 25 VIAL in 1 CARTON (16714-130-25) / 1 mL in 1 VIAL | November 19, 2019 |
| 16714-140-01 | 16714-140 | NorthStar Rx LLC | 1 VIAL in 1 CARTON (16714-140-01) / 5 mL in 1 VIAL | November 19, 2019 |
| 16714-150-01 | 16714-150 | NorthStar Rx LLC | 1 VIAL in 1 CARTON (16714-150-01) / 10 mL in 1 VIAL | November 19, 2019 |
| 71205-451-01 | 71205-451 | Proficient Rx LP | 1 VIAL, SINGLE-DOSE in 1 CARTON (71205-451-01) / 1 mL in 1 VIAL, SINGLE-DOSE | April 23, 2020 |
| 70518-4582-0 | 70518-4582 | REMEDYREPACK INC. | 1 VIAL, MULTI-DOSE in 1 CARTON (70518-4582-0) / 10 mL in 1 VIAL, MULTI-DOSE | March 9, 2026 |
| 25021-054-01 | 25021-054 | Sagent Pharmaceuticals | 25 VIAL in 1 CARTON (25021-054-01) / 1 mL in 1 VIAL | March 1, 2026 |
| 25021-054-05 | 25021-054 | Sagent Pharmaceuticals | 1 VIAL in 1 CARTON (25021-054-05) / 5 mL in 1 VIAL | August 15, 2026 |
| 25021-054-10 | 25021-054 | Sagent Pharmaceuticals | 1 VIAL in 1 CARTON (25021-054-10) / 10 mL in 1 VIAL | August 15, 2026 |
| 85766-016-10 | 85766-016 | Sportpharm LLC | 1 VIAL in 1 CARTON (85766-016-10) / 10 mL in 1 VIAL | June 20, 2025 |
| 85766-134-05 | 85766-134 | Sportpharm LLC | 1 VIAL in 1 CARTON (85766-134-05) / 5 mL in 1 VIAL | January 20, 2026 |
| 85766-194-10 | 85766-194 | Sportpharm LLC | 1 VIAL, MULTI-DOSE in 1 CARTON (85766-194-10) / 10 mL in 1 VIAL, MULTI-DOSE | April 1, 2026 |
| 85766-206-05 | 85766-206 | Sportpharm LLC | 1 VIAL, MULTI-DOSE in 1 CARTON (85766-206-05) / 5 mL in 1 VIAL, MULTI-DOSE | May 7, 2026 |
| 0703-0241-01 | 0703-0241 | Teva Parenteral Medicines, Inc. | 1 VIAL, SINGLE-DOSE in 1 CARTON (0703-0241-01) / 1 mL in 1 VIAL, SINGLE-DOSE | August 29, 2019 |
| 0703-0243-01 | 0703-0243 | Teva Parenteral Medicines, Inc. | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-0243-01) / 5 mL in 1 VIAL, MULTI-DOSE | August 29, 2019 |
| 0703-0245-01 | 0703-0245 | Teva Parenteral Medicines, Inc. | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-0245-01) / 10 mL in 1 VIAL, MULTI-DOSE | August 29, 2019 |
| 76420-016 | 76420-016 | ASCLEMED USA INC. | — | November 19, 2019 |
| 87063-077 | 87063-077 | ASCLEMED USA INC. | — | November 19, 2019 |
| 80425-0262 | 80425-0262 | Advanced Rx Pharmacy of Tennessee, LLC | — | February 15, 2023 |
| 62332-090 | 62332-090 | Alembic Pharmaceuticals Inc. | — | October 17, 2025 |
| 62332-091 | 62332-091 | Alembic Pharmaceuticals Inc. | — | October 17, 2025 |
| 62332-812 | 62332-812 | Alembic Pharmaceuticals Inc. | — | October 17, 2025 |
| 46708-090 | 46708-090 | Alembic Pharmaceuticals Limited | — | October 17, 2025 |
| 46708-091 | 46708-091 | Alembic Pharmaceuticals Limited | — | October 17, 2025 |
| 46708-812 | 46708-812 | Alembic Pharmaceuticals Limited | — | October 17, 2025 |
| 70121-1049 | 70121-1049 | Amneal Pharmaceuticals LLC | — | December 11, 2017 |
| 70121-1168 | 70121-1168 | Amneal Pharmaceuticals LLC | — | December 11, 2017 |
| 70121-1169 | 70121-1169 | Amneal Pharmaceuticals LLC | — | December 11, 2017 |
| 70121-1651 | 70121-1651 | Amneal Pharmaceuticals LLC | — | December 11, 2017 |
| 70121-1652 | 70121-1652 | Amneal Pharmaceuticals LLC | — | December 11, 2017 |
| 70121-1653 | 70121-1653 | Amneal Pharmaceuticals LLC | — | December 11, 2017 |
| 70121-1654 | 70121-1654 | Amneal Pharmaceuticals LLC | — | December 11, 2017 |
| 70121-1655 | 70121-1655 | Amneal Pharmaceuticals LLC | — | December 11, 2017 |
| 70121-1657 | 70121-1657 | Amneal Pharmaceuticals LLC | — | December 11, 2017 |
| 43598-677 | 43598-677 | Dr. Reddy's Laboratories Inc | — | October 20, 2025 |
| 43598-694 | 43598-694 | Dr. Reddy's Laboratories Inc | — | October 20, 2025 |
| 43598-695 | 43598-695 | Dr. Reddy's Laboratories Inc | — | October 20, 2025 |
| 43598-676 | 43598-676 | Dr. Reddy's Labortories Inc | — | August 4, 2025 |
| 55150-384 | 55150-384 | Eugia US LLC | — | July 5, 2022 |
| 55150-385 | 55150-385 | Eugia US LLC | — | July 5, 2022 |
| 0143-9387 | 0143-9387 | Hikma Pharmaceuticals USA Inc. | — | March 3, 2025 |
| 67457-621 | 67457-621 | Mylan Institutional LLC | — | May 8, 2023 |
| 67457-622 | 67457-622 | Mylan Institutional LLC | — | May 8, 2023 |
| 67457-623 | 67457-623 | Mylan Institutional LLC | — | May 8, 2023 |
| 16714-130 | 16714-130 | NorthStar Rx LLC | — | November 19, 2019 |
| 16714-140 | 16714-140 | NorthStar Rx LLC | — | November 19, 2019 |
| 16714-150 | 16714-150 | NorthStar Rx LLC | — | November 19, 2019 |
| 71205-451 | 71205-451 | Proficient Rx LP | — | August 29, 2019 |
| 70518-4582 | 70518-4582 | REMEDYREPACK INC. | — | March 9, 2026 |
| 25021-054 | 25021-054 | Sagent Pharmaceuticals | — | March 1, 2026 |
| 85766-016 | 85766-016 | Sportpharm LLC | — | November 19, 2019 |
| 85766-134 | 85766-134 | Sportpharm LLC | — | November 19, 2019 |
| 85766-194 | 85766-194 | Sportpharm LLC | — | December 11, 2017 |
| 85766-206 | 85766-206 | Sportpharm LLC | — | December 11, 2017 |
| 0703-0241 | 0703-0241 | Teva Parenteral Medicines, Inc. | — | August 29, 2019 |
| 0703-0243 | 0703-0243 | Teva Parenteral Medicines, Inc. | — | August 29, 2019 |
| 0703-0245 | 0703-0245 | Teva Parenteral Medicines, Inc. | — | August 29, 2019 |
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.