FDA Orange Book
Generic for Cardizem CD
Cardizem CD 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 CD is diltiazem. 17 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 CD products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | 120MG | Marketed (Rx) | AB3 | 20 | AB1, AB3, AB2, AB4 |
| capsule, extended release, oral | 180MG | Marketed (Rx) | AB3 | 14 | AB3, AB2, AB4 |
| capsule, extended release, oral | 240MG | Marketed (Rx) | AB3 | 14 | AB3, AB2, AB4 |
| capsule, extended release, oral | 300MG | Marketed (Rx) | AB3 | 10 | AB3, AB4 |
| capsule, extended release, oral | 360MG | Marketed (Rx) | AB3 | 9 | AB4, AB3 |
NDA 020062, held by BAUSCH HEALTH US LLC. 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 |
| ACTAVIS LABORATORIES FL INC | 074752 | AB3 (A-rated, therapeutically equivalent) | July 9, 1998 | 120MG, 180MG, 240MG, 300MG |
| PH HEALTH LTD | 074984 | AB3 (A-rated, therapeutically equivalent) | December 20, 1999 | 120MG, 180MG, 240MG, 300MG |
| VALEANT PHARMACEUTICALS NORTH AMERICA LLC | 075116 | AB3 (A-rated, therapeutically equivalent) | December 23, 1999 | 120MG, 180MG, 240MG, 300MG |
| APOTEX INC | 074943 | AB2 (A-rated, therapeutically equivalent) | December 19, 2000 | 120MG, 180MG, 240MG |
| CHARTWELL RX SCIENCES LLC | 091022 | AB4 (A-rated, therapeutically equivalent) | September 28, 2012 | 120MG, 180MG, 240MG, 300MG, 360MG |
| ACTAVIS ELIZABETH LLC | 202463 | AB3 (A-rated, therapeutically equivalent) | December 7, 2012 | 360MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 203023 | AB3 (A-rated, therapeutically equivalent) | June 8, 2017 | 360MG |
| ZYDUS PHARMACEUTICALS USA INC | 206534 | AB3 (A-rated, therapeutically equivalent) | August 8, 2017 | 120MG, 180MG, 240MG, 300MG, 360MG |
| ZYDUS PHARMACEUTICALS USA INC | 206641 | AB4 (A-rated, therapeutically equivalent) | August 11, 2017 | 120MG, 180MG, 240MG, 300MG, 360MG |
| TWI PHARMACEUTICALS INC | 205231 | AB3 (A-rated, therapeutically equivalent) | August 30, 2018 | 120MG, 180MG, 240MG, 300MG, 360MG |
| NOVAST LABORATORIES LTD | 208783 | AB3 (A-rated, therapeutically equivalent) | June 14, 2019 | 120MG, 180MG, 240MG, 300MG, 360MG |
| ACCORD HEALTHCARE INC | 206997 | AB2 (A-rated, therapeutically equivalent) | April 28, 2020 | 120MG, 180MG, 240MG |
| GLENMARK PHARMACEUTICALS LTD | 212317 | AB1 (A-rated, therapeutically equivalent) | March 22, 2021 | 120MG |
| DR REDDYS LABORATORIES SA | 215775 | AB1 (A-rated, therapeutically equivalent) | May 5, 2022 | 120MG |
| UTOPIC PHARMACEUTICALS INC | 216304 | AB2 (A-rated, therapeutically equivalent) | August 8, 2022 | 120MG, 180MG, 240MG |
| TWI PHARMACEUTICALS INC | 217377 | AB1 (A-rated, therapeutically equivalent) | March 1, 2023 | 120MG |
| ALEMBIC PHARMACEUTICALS LTD | 218587 | AB2 (A-rated, therapeutically equivalent) | October 18, 2024 | 120MG, 180MG, 240MG |
| ALEMBIC PHARMACEUTICALS LTD | 216968 | AB3 (A-rated, therapeutically equivalent) | November 8, 2024 | 120MG, 180MG, 240MG, 300MG, 360MG |
| UTOPIC PHARMACEUTICALS INC | 219073 | AB1 (A-rated, therapeutically equivalent) | March 24, 2025 | 120MG |
| NOVAST LABORATORIES LTD | 218032 | AB1 (A-rated, therapeutically equivalent) | July 2, 2025 | 120MG |
| MACLEODS PHARMACEUTICALS LTD | 218744 | AB3 (A-rated, therapeutically equivalent) | February 27, 2026 | 120MG, 180MG, 240MG, 300MG, 360MG |
Cardizem CD NDC codes
Questions
Is there a generic for Cardizem CD?
Yes. The generic name for Cardizem CD is diltiazem. 17 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 CD?
The active ingredient in Cardizem CD 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.
More on Cardizem CD and Diltiazem
- What is Diltiazem used for?FDA label uses
- Is Diltiazem a controlled substance?Federal schedule
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