FDA Orange Book

Generic for Cardizem LA

Cardizem LA 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 LA is diltiazem. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

Run it in Rivvi

Map Cardizem LA and your other top fills to their generics

Every strength in RxNorm, with brands that have no generic flagged.

Build the map

Free to start. Opens Rivvi, the AI workspace for healthcare teams.

Cardizem LA products in the Orange Book

Cardizem LA products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, extended release, oral	120MG	Marketed (Rx)	AB	3	AB
tablet, extended release, oral	180MG	Marketed (Rx)	AB	3	AB
tablet, extended release, oral	240MG	Marketed (Rx)	AB	3	AB
tablet, extended release, oral	300MG	Marketed (Rx)	AB	3	AB
tablet, extended release, oral	360MG	Marketed (Rx)	AB	3	AB
tablet, extended release, oral	420MG	Marketed (Rx)	AB	3	AB

NDA 021392, 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

Approved generic versions of Cardizem LA
Company	ANDA	TE code	Approved	Strengths
ACTAVIS LABORATORIES FL INC	077686	AB (A-rated, therapeutically equivalent)	March 15, 2010	120MG, 180MG, 240MG, 300MG, 360MG, 420MG
AMTA LABS LTD	216439	AB (A-rated, therapeutically equivalent)	March 7, 2023	120MG, 180MG, 240MG, 300MG, 360MG, 420MG
SCIEGEN PHARMACEUTICALS INC	216327	AB (A-rated, therapeutically equivalent)	April 6, 2023	120MG, 180MG, 240MG, 300MG, 360MG, 420MG

Cardizem LA NDC codes

Questions

Is there a generic for Cardizem LA?

Yes. The generic name for Cardizem LA is diltiazem. 3 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 Cardizem LA?

The active ingredient in Cardizem LA 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.