FDA Orange Book
Generic for Corphedra
Corphedra 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 Corphedra is ephedrine. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Corphedra products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 50MG/ML (50MG/ML) | Marketed (Rx) | AP | 12 | AP |
NDA 208943, held by PH HEALTH LTD. 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) |
| BAXTER HEALTHCARE CORP | 216740 | AP (A-rated, therapeutically equivalent) | July 8, 2026 | 50MG/ML (50MG/ML) |
Corphedra NDC codes
Questions
Is there a generic for Corphedra?
Yes. The generic name for Corphedra is ephedrine. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Corphedra?
The active ingredient in Corphedra 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.