Matzim LA — Tablet, Extended Release

Overview

Brand name

Matzim LA

Generic name

Diltiazem Hydrochloride

Dosage form

Tablet, Extended Release

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Actavis Pharma, Inc.

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

5

NDC product codes

5

Packages

10

Data completeness

60% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Diltiazem Hydrochloride	180 mg/1	831054	View
Diltiazem Hydrochloride	240 mg/1	831054	View
Diltiazem Hydrochloride	300 mg/1	831054	View
Diltiazem Hydrochloride	360 mg/1	831054	View
Diltiazem Hydrochloride	420 mg/1	831054	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet, Extended Release

Route of administration

Oral

Presentations

15

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Calcium Channel Antagonists [MoA]	MoA	All 75 members
Calcium Channel Blocker [EPC]	EPC	All 55 members
Cytochrome P450 3A4 Inhibitors [MoA]	MoA	All 118 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

077686

Application type

ANDA · Abbreviated New Drug Application

Approval date

March 15, 2010

Sponsor

ACTAVIS LABS FL INC

Products on application

6

Submissions recorded

6

Products approved under application 077686.
Product	Trade name	Form	Ingredient	Status	TE
077686-001	DILTIAZEM HYDROCHLORIDE	TABLET, EXTENDED RELEASE	DILTIAZEM HYDROCHLORIDE	Prescription	AB
077686-002	DILTIAZEM HYDROCHLORIDE	TABLET, EXTENDED RELEASE	DILTIAZEM HYDROCHLORIDE	Prescription	AB
077686-003	DILTIAZEM HYDROCHLORIDE	TABLET, EXTENDED RELEASE	DILTIAZEM HYDROCHLORIDE	Prescription	AB
077686-004	DILTIAZEM HYDROCHLORIDE	TABLET, EXTENDED RELEASE	DILTIAZEM HYDROCHLORIDE	Prescription	AB
077686-005	DILTIAZEM HYDROCHLORIDE	TABLET, EXTENDED RELEASE	DILTIAZEM HYDROCHLORIDE	Prescription	AB
077686-006	DILTIAZEM HYDROCHLORIDE	TABLET, EXTENDED RELEASE	DILTIAZEM HYDROCHLORIDE	Prescription	AB

Therapeutic equivalence

Source: Orange Book

TE code

AB

Reference Listed Drug

No

Reference Standard

No

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA

Most recent submissions on application 077686.
Type	No.	Action	Status	Date	Review
Supplement	23	Labeling	Approved	April 9, 2026	Standard
Supplement	19	Labeling	Approved	August 13, 2024	Standard
Supplement	11	Labeling	Approved	July 16, 2024	Standard
Supplement	10	Labeling	Approved	November 8, 2016	Standard
Supplement	5	Labeling	Approved	April 21, 2011	—
Original application	1		Approved	March 15, 2010	—

Adverse event reports

Source: openFDA FAERS

34,216

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: DILTIAZEM HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
52544-691-19	52544-691	Actavis Pharma, Inc.	90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (52544-691-19)	March 28, 2011
52544-691-30	52544-691	Actavis Pharma, Inc.	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (52544-691-30)	March 28, 2011
52544-692-19	52544-692	Actavis Pharma, Inc.	90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (52544-692-19)	March 28, 2011
52544-692-30	52544-692	Actavis Pharma, Inc.	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (52544-692-30)	March 28, 2011
52544-693-19	52544-693	Actavis Pharma, Inc.	90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (52544-693-19)	March 28, 2011
52544-693-30	52544-693	Actavis Pharma, Inc.	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (52544-693-30)	March 28, 2011
52544-694-19	52544-694	Actavis Pharma, Inc.	90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (52544-694-19)	March 28, 2011
52544-694-30	52544-694	Actavis Pharma, Inc.	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (52544-694-30)	March 28, 2011
52544-695-19	52544-695	Actavis Pharma, Inc.	90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (52544-695-19)	March 28, 2011
52544-695-30	52544-695	Actavis Pharma, Inc.	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (52544-695-30)	March 28, 2011
52544-691	52544-691	Actavis Pharma, Inc.	—	March 28, 2011
52544-692	52544-692	Actavis Pharma, Inc.	—	March 28, 2011
52544-693	52544-693	Actavis Pharma, Inc.	—	March 28, 2011
52544-694	52544-694	Actavis Pharma, Inc.	—	March 28, 2011
52544-695	52544-695	Actavis Pharma, Inc.	—	March 28, 2011

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Orange Book	FDA	Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.