FDA Orange Book
Generic for Cardizem SR
Cardizem SR contains diltiazem. 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 Cardizem SR is diltiazem. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2, AB3, AB4.
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Cardizem SR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | 120MG | Discontinued | None | 20 | AB1, AB3, AB2, AB4 |
| capsule, extended release, oral | 180MG | Discontinued | None | 14 | AB3, AB2, AB4 |
| capsule, extended release, oral | 60MG | Discontinued | None | 6 | AB1 |
| capsule, extended release, oral | 90MG | Discontinued | None | 6 | AB1 |
NDA 019471, held by BIOVAIL LABORATORIES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic diltiazem
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 074910 | AB1 (A-rated, therapeutically equivalent) | May 2, 1997 | 120MG, 60MG, 90MG |
| ACTAVIS LABORATORIES FL INC | 074752 | AB3 (A-rated, therapeutically equivalent) | July 9, 1998 | 120MG, 180MG |
| PH HEALTH LTD | 074984 | AB3 (A-rated, therapeutically equivalent) | December 20, 1999 | 120MG, 180MG |
| VALEANT PHARMACEUTICALS NORTH AMERICA LLC | 075116 | AB3 (A-rated, therapeutically equivalent) | December 23, 1999 | 120MG, 180MG |
| APOTEX INC | 074943 | AB2 (A-rated, therapeutically equivalent) | December 19, 2000 | 120MG, 180MG |
| CHARTWELL RX SCIENCES LLC | 091022 | AB4 (A-rated, therapeutically equivalent) | September 28, 2012 | 120MG, 180MG |
| ZYDUS PHARMACEUTICALS USA INC | 206534 | AB3 (A-rated, therapeutically equivalent) | August 8, 2017 | 120MG, 180MG |
| ZYDUS PHARMACEUTICALS USA INC | 206641 | AB4 (A-rated, therapeutically equivalent) | August 11, 2017 | 120MG, 180MG |
| TWI PHARMACEUTICALS INC | 205231 | AB3 (A-rated, therapeutically equivalent) | August 30, 2018 | 120MG, 180MG |
| NOVAST LABORATORIES LTD | 208783 | AB3 (A-rated, therapeutically equivalent) | June 14, 2019 | 120MG, 180MG |
| ACCORD HEALTHCARE INC | 206997 | AB2 (A-rated, therapeutically equivalent) | April 28, 2020 | 120MG, 180MG |
| GLENMARK PHARMACEUTICALS LTD | 212317 | AB1 (A-rated, therapeutically equivalent) | March 22, 2021 | 120MG, 60MG, 90MG |
| DR REDDYS LABORATORIES SA | 215775 | AB1 (A-rated, therapeutically equivalent) | May 5, 2022 | 120MG, 60MG, 90MG |
| UTOPIC PHARMACEUTICALS INC | 216304 | AB2 (A-rated, therapeutically equivalent) | August 8, 2022 | 120MG, 180MG |
| TWI PHARMACEUTICALS INC | 217377 | AB1 (A-rated, therapeutically equivalent) | March 1, 2023 | 120MG, 60MG, 90MG |
| ALEMBIC PHARMACEUTICALS LTD | 218587 | AB2 (A-rated, therapeutically equivalent) | October 18, 2024 | 120MG, 180MG |
| ALEMBIC PHARMACEUTICALS LTD | 216968 | AB3 (A-rated, therapeutically equivalent) | November 8, 2024 | 120MG, 180MG |
| UTOPIC PHARMACEUTICALS INC | 219073 | AB1 (A-rated, therapeutically equivalent) | March 24, 2025 | 120MG, 60MG, 90MG |
| NOVAST LABORATORIES LTD | 218032 | AB1 (A-rated, therapeutically equivalent) | July 2, 2025 | 120MG, 60MG, 90MG |
| MACLEODS PHARMACEUTICALS LTD | 218744 | AB3 (A-rated, therapeutically equivalent) | February 27, 2026 | 120MG, 180MG |
Questions
Is there a generic for Cardizem SR?
Yes. The generic name for Cardizem SR is diltiazem. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1, AB2, AB3, AB4.
What is the generic name for Cardizem SR?
The active ingredient in Cardizem SR is diltiazem, 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.