FDA Orange Book
Generic for Cardene
Cardene contains nicardipine. 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 Cardene is nicardipine. 14 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
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Cardene products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 20MG | Discontinued | None | 6 | AB |
| capsule, oral | 30MG | Discontinued | None | 6 | AB |
| injectable, injection | 25MG/10ML (2.5MG/ML) | Marketed (Rx) | AP | 8 | AP |
NDA 019488, 019734, held by CHIESI USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic nicardipine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ANI PHARMACEUTICALS INC | 074670 | AB (A-rated, therapeutically equivalent) | October 28, 1996 | 20MG, 30MG |
| EPIC PHARMA LLC | 074928 | AB (A-rated, therapeutically equivalent) | March 19, 1998 | 20MG, 30MG |
| AMERICAN REGENT INC | 090534 | AP (A-rated, therapeutically equivalent) | November 17, 2009 | 25MG/10ML (2.5MG/ML) |
| MANKIND PHARMA LTD | 090671 | AP (A-rated, therapeutically equivalent) | November 17, 2009 | 25MG/10ML (2.5MG/ML) |
| SOMERSET THERAPEUTICS LLC | 090664 | AP (A-rated, therapeutically equivalent) | November 17, 2009 | 25MG/10ML (2.5MG/ML) |
| EUGIA PHARMA SPECIALITIES LTD | 211121 | AP (A-rated, therapeutically equivalent) | April 8, 2021 | 25MG/10ML (2.5MG/ML) |
| GLENMARK PHARMACEUTICALS LTD | 216357 | AB (A-rated, therapeutically equivalent) | December 16, 2022 | 20MG, 30MG |
| BIONPHARMA INC | 217555 | AB (A-rated, therapeutically equivalent) | May 3, 2023 | 20MG, 30MG |
| MICRO LABS LTD | 216420 | AP (A-rated, therapeutically equivalent) | July 7, 2023 | 25MG/10ML (2.5MG/ML) |
| PHARMAZONE | 215377 | AB (A-rated, therapeutically equivalent) | July 17, 2023 | 20MG, 30MG |
| AMNEAL PHARMACEUTICALS LLC | 218202 | AB (A-rated, therapeutically equivalent) | April 10, 2024 | 20MG, 30MG |
| CHENGDU SHUODE PHARMACEUTICAL CO LTD | 217548 | AP (A-rated, therapeutically equivalent) | September 6, 2024 | 25MG/10ML (2.5MG/ML) |
| NANJING KING FRIEND BIOCHEMICAL PHARMACEUTICAL CO LTD | 216819 | AP (A-rated, therapeutically equivalent) | August 20, 2025 | 25MG/10ML (2.5MG/ML) |
| QILU PHARMACEUTICAL HAINAN CO LTD | 219608 | AP (A-rated, therapeutically equivalent) | October 28, 2025 | 25MG/10ML (2.5MG/ML) |
Cardene NDC codes
Questions
Is there a generic for Cardene?
Yes. The generic name for Cardene is nicardipine. 14 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
What is the generic name for Cardene?
The active ingredient in Cardene is nicardipine, 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.