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.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 080399 | PRASCO | 1971-10-20 | 3 |
| ANDA 084282 | HIKMA | 1975-07-15 | 12 |
| ANDA 084754 | KANCHAN HLTHCARE | 1976-09-21 | 5 |
| ANDA 084916 | FRESENIUS KABI USA | 1977-09-06 | 7 |
| ANDA 084612 | HIKMA | 1978-07-19 | 23 |
| ANDA 087702 | HIKMA | 1982-09-07 | 7 |
| ANDA 088237 | KEY THERAP | 1983-04-28 | 2 |
| ANDA 088149 | PANGEA | 1983-04-28 | 2 |
| ANDA 088252 | HIKMA | 1983-09-01 | 2 |
| ANDA 088316 | HIKMA | 1983-09-15 | 1 |
| ANDA 088481 | ALVOGEN | 1983-12-15 | 6 |
| ANDA 040069 | BAUSCH AND LOMB INC | 1996-07-26 | 1 |
| ANDA 040491 | FRESENIUS KABI USA | 2003-04-11 | 4 |
| ANDA 040572 | FRESENIUS KABI USA | 2005-04-22 | 2 |
| ANDA 040802 | MYLAN LABS LTD | 2008-08-29 | 6 |
| ANDA 040803 | MYLAN LABS LTD | 2008-08-29 | 21 |
| ANDA 091188 | CHARTWELL MOLECULAR | 2011-05-11 | 1 |
| ANDA 090891 | RISING | 2011-07-12 | 1 |
| ANDA 203129 | FRESENIUS KABI USA | 2015-09-30 | 2 |
| ANDA 206781 | EUGIA PHARMA | 2015-12-01 | 9 |
| ANDA 201270 | PHARMOBEDIENT | 2017-07-17 | 5 |
| ANDA 207442 | SOMERSET THERAPS LLC | 2018-04-19 | 2 |
| ANDA 207521 | SOMERSET | 2018-06-08 | 3 |
| ANDA 209192 | FRESENIUS KABI USA | 2018-07-06 | 2 |
| ANDA 208689 | AMNEAL | 2018-08-22 | 3 |
| ANDA 211036 | SOMERSET THERAPS LLC | 2019-05-10 | 2 |
| ANDA 210967 | EUGIA PHARMA | 2019-06-07 | 3 |
| ANDA 215654 | GLAND | 2021-08-04 | 7 |
| ANDA 215106 | AMNEAL | 2021-10-14 | 6 |
| ANDA 215604 | NOVITIUM PHARMA | 2022-08-08 | 20 |
| ANDA 216295 | AMNEAL | 2022-09-08 | 2 |
| ANDA 217001 | BIONPHARMA | 2023-04-19 | 8 |
| ANDA 217538 | BIONPHARMA | 2023-04-26 | 1 |
| ANDA 217696 | NOVITIUM PHARMA | 2023-05-09 | 4 |
| ANDA 217695 | APOTEX | 2023-08-23 | 10 |
| ANDA 216283 | ZYDUS LIFESCIENCES | 2024-02-07 | 2 |
| ANDA 216282 | ZYDUS LIFESCIENCES | 2024-02-07 | 16 |
| ANDA 217797 | MICRO LABS | 2024-03-27 | 2 |
| ANDA 216284 | ZYDUS LIFESCIENCES | 2024-05-09 | 2 |
| ANDA 218372 | COREPHARMA | 2024-09-17 | 9 |
Showing 40 of 47 applications.
Official labeling on DailyMed
- DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [REMEDYREPACK INC.] · version 3 · 2026-09-10
- DEXAMETHASONE TABLET [REMEDYREPACK INC.] · version 3 · 2026-09-07
- DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE) INJECTION, SOLUTION [MICRO LABS LIMITED] · version 4 · 2026-09-02
- DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [SPORTPHARM LLC] · version 1 · 2026-09-02
- DEXAMETHASONE INTENSOL SOLUTION, CONCENTRATE [SPORTPHARM LLC] · version 1 · 2026-08-28
- DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] · version 2 · 2026-08-24
- DEXAMETHASONE SODIUM PHOSPHATE INJECTION [ASCLEMED USA INC.] · version 1 · 2026-08-12
- DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] · version 7 · 2026-08-03
- DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] · version 12 · 2026-08-03
- DEXAMETHASONE TABLET [SPORTPHARM LLC] · version 1 · 2026-07-20
- DEXAMETHASONE SODIUM PHOSPHATE INJECTION, SOLUTION [SPORTPHARM LLC] · version 1 · 2026-07-20
- DEXAMETHASONE TABLET [REMEDYREPACK INC.] · version 15 · 2026-07-08
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.