FDA Orange Book
Generic for Decadron
Decadron contains dexamethasone. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Decadron is dexamethasone. 19 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB, AP, BP. Generics match 9 of the 12 Decadron products the Orange Book lists.
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Decadron products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | EQ 0.1% PHOSPHATE | Discontinued | None | 0 | None |
| elixir, oral | 0.5MG/5ML | Discontinued | None | 3 | AA |
| injectable, injection | EQ 24MG PHOSPHATE/ML | Discontinued | None | 0 | None |
| injectable, injection | EQ 4MG PHOSPHATE/ML | Discontinued | None | 7 | AP |
| ointment, ophthalmic | EQ 0.05% PHOSPHATE | Discontinued | None | 0 | None |
| solution/drops, ophthalmic, otic | EQ 0.1% PHOSPHATE | Discontinued | None | 1 | None |
| tablet, oral | 0.25MG | Discontinued | None | 1 | None |
| tablet, oral | 0.5MG | Discontinued | None | 6 | AB, BP |
| tablet, oral | 0.75MG | Discontinued | None | 6 | AB, BP |
| tablet, oral | 1.5MG | Discontinued | None | 6 | AB |
| tablet, oral | 4MG | Discontinued | None | 9 | AB |
| tablet, oral | 6MG | Discontinued | None | 8 | AB |
NDA 011983, 012376, 012071, 011977, 011984, 011664, held by MERCK AND CO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic dexamethasone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PANGEA PHARMACEUTICALS LLC | 088149 | None (No TE code listed) | April 28, 1983 | 0.25MG |
| ALVOGEN INC | 088481 | BP (B-rated, not considered equivalent) | April 28, 1983 | 0.5MG, 0.75MG, 4MG, 6MG |
| BAUSCH AND LOMB INC | 040069 | None (No TE code listed) | July 26, 1996 | EQ 0.1% PHOSPHATE |
| MYLAN LABORATORIES LTD | 040803 | AP (A-rated, therapeutically equivalent) | August 29, 2008 | EQ 4MG PHOSPHATE/ML |
| CHARTWELL MOLECULAR HOLDINGS LLC | 091188 | AA (A-rated, therapeutically equivalent) | May 11, 2011 | 0.5MG/5ML |
| RISING PHARMA HOLDINGS INC | 090891 | AA (A-rated, therapeutically equivalent) | July 12, 2011 | 0.5MG/5ML |
| FRESENIUS KABI USA LLC | 203129 | AP (A-rated, therapeutically equivalent) | September 30, 2015 | EQ 4MG PHOSPHATE/ML |
| PHARMOBEDIENT CONSULTING LLC | 201270 | AB (A-rated, therapeutically equivalent) | July 17, 2017 | 1.5MG |
| SOMERSET THERAPEUTICS LLC | 207521 | AP (A-rated, therapeutically equivalent) | June 8, 2018 | EQ 4MG PHOSPHATE/ML |
| AMNEAL EU LTD | 208689 | AP (A-rated, therapeutically equivalent) | August 22, 2018 | EQ 4MG PHOSPHATE/ML |
| GLAND PHARMA LTD | 215654 | AP (A-rated, therapeutically equivalent) | August 4, 2021 | EQ 4MG PHOSPHATE/ML |
| AMNEAL EU LTD | 215106 | AB (A-rated, therapeutically equivalent) | October 14, 2021 | 4MG, 6MG |
| PRASCO LLC DBA PRASCO LABORATORIES | 080399 | AB (A-rated, therapeutically equivalent) | April 20, 2022 | 4MG |
| BIONPHARMA INC | 217001 | AB (A-rated, therapeutically equivalent) | April 19, 2023 | 4MG, 6MG |
| APOTEX INC | 217695 | AB (A-rated, therapeutically equivalent) | August 23, 2023 | 0.5MG, 0.75MG, 1.5MG, 4MG, 6MG |
| NOVITIUM PHARMA LLC | 215604 | AB (A-rated, therapeutically equivalent) | October 5, 2023 | 0.5MG, 0.75MG, 1.5MG, 4MG, 6MG |
| ZYDUS LIFESCIENCES LTD | 216282 | AB (A-rated, therapeutically equivalent) | February 7, 2024 | 0.5MG, 0.75MG, 1.5MG, 4MG, 6MG |
| SOLGEN PHARMA LLC | 218372 | AB (A-rated, therapeutically equivalent) | September 17, 2024 | 0.5MG, 0.75MG, 1.5MG, 4MG, 6MG |
| PHARMAZONE | 084754 | AA (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 0.5MG/5ML |
| FRESENIUS KABI USA LLC | 084916 | AP (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | EQ 4MG PHOSPHATE/ML |
| HIKMA PHARMACEUTICALS USA INC | 084282 | AP (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | EQ 4MG PHOSPHATE/ML |
| HIKMA PHARMACEUTICALS USA INC | 084612 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 0.5MG, 0.75MG, 1.5MG, 4MG, 6MG |
Questions
Is there a generic for Decadron?
Yes. The generic name for Decadron is dexamethasone. 19 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB, AP, BP. Generics match 9 of the 12 Decadron products the Orange Book lists.
What is the generic name for Decadron?
The active ingredient in Decadron is dexamethasone, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.