FDA Orange Book
Generic for Cardizem
Cardizem 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 is diltiazem. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP. Generics match 6 of the 7 Cardizem products the Orange Book lists.
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Cardizem products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 100MG/VIAL | Discontinued | None | 1 | None |
| injectable, injection | 25MG/VIAL | Discontinued | None | 0 | None |
| injectable, injection | 5MG/ML | Discontinued | None | 3 | AP |
| tablet, oral | 120MG | Marketed (Rx) | AB | 5 | AB |
| tablet, oral | 30MG | Marketed (Rx) | AB | 5 | AB |
| tablet, oral | 60MG | Marketed (Rx) | AB | 5 | AB |
| tablet, oral | 90MG | Marketed (Rx) | AB | 5 | AB |
NDA 020792, 020027, 018602, 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 |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 074185 | AB (A-rated, therapeutically equivalent) | May 31, 1995 | 120MG, 30MG, 60MG, 90MG |
| SAGENT PHARMACEUTICALS | 074617 | AP (A-rated, therapeutically equivalent) | February 28, 1996 | 5MG/ML |
| RISING PHARMA HOLDINGS INC | 075086 | AP (A-rated, therapeutically equivalent) | April 9, 1998 | 5MG/ML |
| HOSPIRA INC | 075853 | None (No TE code listed) | December 17, 2002 | 100MG/VIAL |
| HIKMA PHARMACEUTICALS USA INC | 078538 | AP (A-rated, therapeutically equivalent) | December 17, 2008 | 5MG/ML |
| SCIEGEN PHARMACEUTICALS INC | 216521 | AB (A-rated, therapeutically equivalent) | September 23, 2022 | 120MG, 30MG, 60MG, 90MG |
| ZYDUS LIFESCIENCES GLOBAL FZE | 219253 | AB (A-rated, therapeutically equivalent) | August 8, 2025 | 120MG, 30MG, 60MG, 90MG |
| ALEMBIC PHARMACEUTICALS LTD | 217633 | AB (A-rated, therapeutically equivalent) | November 14, 2025 | 120MG, 30MG, 60MG, 90MG |
| YICHANG HUMANWELL PHARMACEUTICAL CO LTD | 220590 | AB (A-rated, therapeutically equivalent) | September 25, 2026 | 120MG, 30MG, 60MG, 90MG |
Cardizem NDC codes
Questions
Is there a generic for Cardizem?
Yes. The generic name for Cardizem is diltiazem. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP. Generics match 6 of the 7 Cardizem products the Orange Book lists.
What is the generic name for Cardizem?
The active ingredient in Cardizem 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 and Diltiazem
- What is Diltiazem used for?FDA label uses
- Is Diltiazem a controlled substance?Federal schedule
- Generic for Cardizem CDFDA Orange Book
- Generic for Cardizem SRFDA Orange Book
- Generic for Dilacor XRFDA Orange Book
- Generic for TiazacFDA Orange Book
- Generic for Cardizem LAFDA Orange Book
- Calcium Channel Blockers listFDA drug class
- NDC 0187-0771Cardizem NDC record
- NDC 0187-0772Cardizem NDC record
- NDC 0187-0792Cardizem NDC record