FDA Orange Book
Generic for Adalat
Adalat contains nifedipine. 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 Adalat is nifedipine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Adalat products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 10MG | Discontinued | None | 4 | AB |
| capsule, oral | 20MG | Discontinued | None | 2 | AB |
NDA 019478, held by BAYER PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic nifedipine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS ELIZABETH LLC | 072579 | AB (A-rated, therapeutically equivalent) | January 8, 1991 | 10MG |
| VELZEN PHARMA PVT LTD | 073250 | AB (A-rated, therapeutically equivalent) | October 8, 1991 | 10MG |
| VELZEN PHARMA PVT LTD | 074045 | AB (A-rated, therapeutically equivalent) | April 30, 1992 | 20MG |
| ACELLA PHARMACEUTICALS LLC | 072781 | AB (A-rated, therapeutically equivalent) | July 30, 1993 | 10MG |
| HERITAGE PHARMA LABS INC | 202644 | AB (A-rated, therapeutically equivalent) | April 25, 2013 | 10MG, 20MG |
Questions
Is there a generic for Adalat?
Yes. The generic name for Adalat is nifedipine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Adalat?
The active ingredient in Adalat is nifedipine, 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.