FDA Orange Book
Generic for Hexadrol
Hexadrol 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 Hexadrol 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 7 of the 8 Hexadrol products the Orange Book lists.
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Hexadrol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| elixir, oral | 0.5MG/5ML | Discontinued | None | 3 | AA |
| injectable, injection | EQ 10MG PHOSPHATE/ML | Discontinued | None | 11 | AP |
| injectable, injection | EQ 20MG PHOSPHATE/ML | Discontinued | None | 0 | None |
| injectable, injection | EQ 4MG PHOSPHATE/ML | Discontinued | None | 7 | AP |
| 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 |
NDA 012674, 014694, 012675, held by ASPEN GLOBAL 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 |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 087702 | AP (A-rated, therapeutically equivalent) | September 7, 1982 | EQ 10MG PHOSPHATE/ML |
| ALVOGEN INC | 088481 | BP (B-rated, not considered equivalent) | April 28, 1983 | 0.5MG, 0.75MG, 4MG |
| FRESENIUS KABI USA LLC | 040491 | AP (A-rated, therapeutically equivalent) | April 11, 2003 | EQ 10MG PHOSPHATE/ML |
| FRESENIUS KABI USA LLC | 040572 | AP (A-rated, therapeutically equivalent) | April 22, 2005 | EQ 10MG PHOSPHATE/ML |
| MYLAN LABORATORIES LTD | 040802 | AP (A-rated, therapeutically equivalent) | August 29, 2008 | EQ 10MG PHOSPHATE/ML |
| 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 | 207442 | AP (A-rated, therapeutically equivalent) | April 19, 2018 | EQ 10MG PHOSPHATE/ML |
| SOMERSET THERAPEUTICS LLC | 207521 | AP (A-rated, therapeutically equivalent) | June 8, 2018 | EQ 4MG PHOSPHATE/ML |
| FRESENIUS KABI USA LLC | 209192 | AP (A-rated, therapeutically equivalent) | July 6, 2018 | EQ 10MG PHOSPHATE/ML |
| AMNEAL EU LTD | 208690 | AP (A-rated, therapeutically equivalent) | August 22, 2018 | EQ 10MG PHOSPHATE/ML |
| AMNEAL EU LTD | 208689 | AP (A-rated, therapeutically equivalent) | August 22, 2018 | EQ 4MG PHOSPHATE/ML |
| SOMERSET THERAPEUTICS LLC | 211036 | AP (A-rated, therapeutically equivalent) | May 10, 2019 | EQ 10MG PHOSPHATE/ML |
| EUGIA PHARMA SPECIALITIES LTD | 210966 | AP (A-rated, therapeutically equivalent) | June 5, 2020 | EQ 10MG PHOSPHATE/ML |
| AMNEAL EU LTD | 215106 | AB (A-rated, therapeutically equivalent) | October 14, 2021 | 4MG |
| 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 |
| APOTEX INC | 217695 | AB (A-rated, therapeutically equivalent) | August 23, 2023 | 0.5MG, 0.75MG, 1.5MG, 4MG |
| GLAND PHARMA LTD | 215654 | AP (A-rated, therapeutically equivalent) | September 25, 2023 | EQ 10MG PHOSPHATE/ML, EQ 4MG PHOSPHATE/ML |
| NOVITIUM PHARMA LLC | 215604 | AB (A-rated, therapeutically equivalent) | October 5, 2023 | 0.5MG, 0.75MG, 1.5MG, 4MG |
| ZYDUS LIFESCIENCES LTD | 216282 | AB (A-rated, therapeutically equivalent) | February 7, 2024 | 0.5MG, 0.75MG, 1.5MG, 4MG |
| MICRO LABS LTD | 217797 | AP (A-rated, therapeutically equivalent) | March 27, 2024 | EQ 10MG PHOSPHATE/ML |
| SOLGEN PHARMA LLC | 218372 | AB (A-rated, therapeutically equivalent) | September 17, 2024 | 0.5MG, 0.75MG, 1.5MG, 4MG |
| 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 |
Questions
Is there a generic for Hexadrol?
Yes. The generic name for Hexadrol 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 7 of the 8 Hexadrol products the Orange Book lists.
What is the generic name for Hexadrol?
The active ingredient in Hexadrol 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.