MedPath
FDA Product

diltiazem hydrochloride

Product approved by U.S. Food and Drug Administration (US)

Basic Information

diltiazem hydrochloride

68151-1480

Regulatory Information

68151-1480

NDA020401

C73605

June 24, 2014

USA

Diltiazem Hydrochloride Extended-Release Capsules

HUMAN PRESCRIPTION DRUG LABEL

3

Company Information

079239644

Active Ingredients

POVIDONES

Code: FZ989GH94E

Class Code: IACT

SUCROSE STEARATE

Code: 274KW0O50M

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

DILTIAZEM HYDROCHLORIDE

Quantity: 120 mg in 1 1

Code: OLH94387TE

Class Code: ACTIB

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

FD&C GREEN NO. 3

Code: 3P3ONR6O1S

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

ETHYL ACRYLATE

Code: 71E6178C9T

Class Code: IACT

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

D&C RED NO. 28

Code: 767IP0Y5NH

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

GELATIN

Code: 2G86QN327L

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

Active Moieties

DILTIAZEM

Code: EE92BBP03H

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