FDA Orange Book
Generic for Adalat Cc
Adalat Cc 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 Cc is nifedipine. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.
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Adalat Cc products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 30MG | Discontinued | None | 12 | AB1, AB2 |
| tablet, extended release, oral | 60MG | Discontinued | None | 12 | AB2, AB1 |
| tablet, extended release, oral | 90MG | Discontinued | None | 12 | AB1, AB2 |
NDA 020198, held by NORWICH PHARMACEUTICALS INC. 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 |
|---|---|---|---|---|
| VALEANT PHARMACEUTICALS NORTH AMERICA LLC | 075269 | AB1 (A-rated, therapeutically equivalent) | December 4, 2000 | 30MG, 60MG |
| VALEANT PHARMACEUTICALS NORTH AMERICA LLC | 075289 | AB2 (A-rated, therapeutically equivalent) | February 6, 2001 | 30MG, 60MG |
| VALEANT PHARMACEUTICALS NORTH AMERICA LLC | 076070 | AB1 (A-rated, therapeutically equivalent) | August 16, 2002 | 90MG |
| OSMOTICA PHARMACEUTICAL US LLC | 077127 | AB2 (A-rated, therapeutically equivalent) | November 21, 2005 | 30MG, 60MG, 90MG |
| AUROBINDO PHARMA USA INC | 090649 | AB2 (A-rated, therapeutically equivalent) | June 21, 2010 | 30MG, 60MG, 90MG |
| TWI PHARMACEUTICALS INC | 203126 | AB2 (A-rated, therapeutically equivalent) | April 3, 2014 | 30MG, 60MG, 90MG |
| NOVAST LABORATORIES LTD | 202987 | AB1 (A-rated, therapeutically equivalent) | August 25, 2016 | 30MG, 60MG, 90MG |
| ZYDUS PHARMACEUTICALS USA INC | 210012 | AB2 (A-rated, therapeutically equivalent) | December 19, 2017 | 30MG, 60MG, 90MG |
| ZYDUS PHARMACEUTICALS USA INC | 210184 | AB1 (A-rated, therapeutically equivalent) | June 29, 2018 | 30MG, 60MG, 90MG |
| NOVAST LABORATORIES LTD | 210614 | AB2 (A-rated, therapeutically equivalent) | March 12, 2019 | 30MG, 60MG, 90MG |
| ELITE PHARMACEUTICAL SOLUTION INC | 212016 | AB2 (A-rated, therapeutically equivalent) | November 18, 2020 | 90MG |
| AUROBINDO PHARMA LTD | 213361 | AB1 (A-rated, therapeutically equivalent) | July 19, 2021 | 30MG, 60MG, 90MG |
| ALKEM LABORATORIES LTD | 216067 | AB2 (A-rated, therapeutically equivalent) | March 29, 2022 | 30MG, 60MG, 90MG |
| ALEMBIC PHARMACEUTICALS LTD | 216896 | AB2 (A-rated, therapeutically equivalent) | November 18, 2022 | 30MG, 60MG, 90MG |
Questions
Is there a generic for Adalat Cc?
Yes. The generic name for Adalat Cc is nifedipine. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2.
What is the generic name for Adalat Cc?
The active ingredient in Adalat Cc 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.