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Active ingredient

Dexamethasone

247 finished FDA listings contain Dexamethasone as their only active ingredient; 65 combination products also contain it.

FDA NDC Directory

Ingredient names as written by FDA
DEXAMETHASONE, DEXAMETHASONE ACETATE ANHYDROUS, DEXAMETHASONE ISONICOTINATE, DEXAMETHASONE SODIUM PHOSPHATE
Dosage forms
Elixir, For Suspension, Implant, Injection, Injection, Emulsion, Injection, Solution, Insert, Ointment, Solution, Solution, Concentrate, Solution/ Drops, Tablet
Routes
Intra-Articular, Intracanalicular, Intralesional, Intramuscular, Intravenous, Intravitreal, Ophthalmic, Oral, Soft Tissue, Topical
Manufacturers / labelers
66
Strengths listed
.075 g/100g · .25 mg/1 · .4 mg/1 · .5 mg/.5mg · .5 mg/1 · .5 mg/5ml · .7 mg/1 · .75 mg/.75mg · .75 mg/1 · 1 mg/1 · 1 mg/ml · 1.5 mg/1 · 10 mg/ml · 100 mg/10ml · 2 mg/1 · 20 mg/1 · 4 mg/1 · 4 mg/ml · 6 mg/1
Brand names in FDA listings
Dextenza, Dmt Suik, Hemady, Maxidex, Ozurdex, Seacall Dexamethasone Ointment., Taperdex 12-Day, Taperdex 6-Day

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 3264

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 080399PRASCO1971-10-203
ANDA 084282HIKMA1975-07-1512
ANDA 084754KANCHAN HLTHCARE1976-09-215
ANDA 084916FRESENIUS KABI USA1977-09-067
ANDA 084612HIKMA1978-07-1923
ANDA 087702HIKMA1982-09-077
ANDA 088237KEY THERAP1983-04-282
ANDA 088149PANGEA1983-04-282
ANDA 088252HIKMA1983-09-012
ANDA 088316HIKMA1983-09-151
ANDA 088481ALVOGEN1983-12-156
ANDA 040069BAUSCH AND LOMB INC1996-07-261
ANDA 040491FRESENIUS KABI USA2003-04-114
ANDA 040572FRESENIUS KABI USA2005-04-222
ANDA 040802MYLAN LABS LTD2008-08-296
ANDA 040803MYLAN LABS LTD2008-08-2921
ANDA 091188CHARTWELL MOLECULAR2011-05-111
ANDA 090891RISING2011-07-121
ANDA 203129FRESENIUS KABI USA2015-09-302
ANDA 206781EUGIA PHARMA2015-12-019
ANDA 201270PHARMOBEDIENT2017-07-175
ANDA 207442SOMERSET THERAPS LLC2018-04-192
ANDA 207521SOMERSET2018-06-083
ANDA 209192FRESENIUS KABI USA2018-07-062
ANDA 208689AMNEAL2018-08-223
ANDA 211036SOMERSET THERAPS LLC2019-05-102
ANDA 210967EUGIA PHARMA2019-06-073
ANDA 215654GLAND2021-08-047
ANDA 215106AMNEAL2021-10-146
ANDA 215604NOVITIUM PHARMA2022-08-0820
ANDA 216295AMNEAL2022-09-082
ANDA 217001BIONPHARMA2023-04-198
ANDA 217538BIONPHARMA2023-04-261
ANDA 217696NOVITIUM PHARMA2023-05-094
ANDA 217695APOTEX2023-08-2310
ANDA 216283ZYDUS LIFESCIENCES2024-02-072
ANDA 216282ZYDUS LIFESCIENCES2024-02-0716
ANDA 217797MICRO LABS2024-03-272
ANDA 216284ZYDUS LIFESCIENCES2024-05-092
ANDA 218372COREPHARMA2024-09-179

Showing 40 of 47 applications.

Official labeling on DailyMed

Showing the 12 most recent of 162 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.