FDA Orange Book
Generic for Akovaz
Akovaz contains ephedrine. 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 Akovaz is ephedrine. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP, AP2, AP3.
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Akovaz products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 25MG/5ML (5MG/ML) | Marketed (Rx) | AP3 | 2 | AP3, AP2 |
| solution, intravenous | 50MG/ML (50MG/ML) | Marketed (Rx) | AP | 12 | AP |
NDA 208289, held by EXELA PHARMA SCIENCES LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ephedrine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 209784 | AP (A-rated, therapeutically equivalent) | August 23, 2017 | 50MG/ML (50MG/ML) |
| AMNEAL EU LTD | 212932 | AP (A-rated, therapeutically equivalent) | October 23, 2019 | 50MG/ML (50MG/ML) |
| FRESENIUS KABI USA LLC | 209646 | AP (A-rated, therapeutically equivalent) | August 4, 2020 | 50MG/ML (50MG/ML) |
| DR REDDYS LABORATORIES LTD | 212649 | AP (A-rated, therapeutically equivalent) | October 3, 2020 | 50MG/ML (50MG/ML) |
| HIKMA PHARMACEUTICALS USA INC | 214334 | AP (A-rated, therapeutically equivalent) | December 15, 2020 | 50MG/ML (50MG/ML) |
| EUGIA PHARMA SPECIALITIES LTD | 214579 | AP (A-rated, therapeutically equivalent) | June 14, 2021 | 50MG/ML (50MG/ML) |
| GLAND PHARMA LTD | 216146 | AP (A-rated, therapeutically equivalent) | February 25, 2022 | 50MG/ML (50MG/ML) |
| MANKIND PHARMA LTD | 216129 | AP (A-rated, therapeutically equivalent) | April 14, 2022 | 50MG/ML (50MG/ML) |
| XIROMED PHARMA ESPANA SL | 215825 | AP (A-rated, therapeutically equivalent) | April 21, 2022 | 50MG/ML (50MG/ML) |
| SAGENT PHARMACEUTICALS INC | 214528 | AP (A-rated, therapeutically equivalent) | March 9, 2023 | 50MG/ML (50MG/ML) |
| CAPLIN STERILES LTD | 219050 | AP (A-rated, therapeutically equivalent) | July 18, 2024 | 50MG/ML (50MG/ML) |
| HIKMA PHARMACEUTICALS USA INC | 217721 | AP3 (A-rated, therapeutically equivalent) | October 11, 2024 | 25MG/5ML (5MG/ML) |
| FRESENIUS KABI USA LLC | 218271 | AP2 (A-rated, therapeutically equivalent) | March 11, 2025 | 25MG/5ML (5MG/ML) |
| BAXTER HEALTHCARE CORP | 216740 | AP (A-rated, therapeutically equivalent) | July 8, 2026 | 50MG/ML (50MG/ML) |
Akovaz NDC codes
Questions
Is there a generic for Akovaz?
Yes. The generic name for Akovaz is ephedrine. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP, AP2, AP3.
What is the generic name for Akovaz?
The active ingredient in Akovaz is ephedrine, 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.