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FDA Product

Diltiazem HCl CD

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

Basic Information

Diltiazem HCl CD

71335-2029

Regulatory Information

71335-2029

NDA020062

C73594

June 8, 2023

USA

Diltiazem Hydrochloride CD Extended-Release Capsules

HUMAN PRESCRIPTION DRUG LABEL

101

Company Information

171714327

Active Ingredients

DILTIAZEM HYDROCHLORIDE

Quantity: 360 mg in 1 1

Code: OLH94387TE

Class Code: ACTIB

Inactive Ingredients

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

HYPROMELLOSE 2910 (10000 MPA.S)

Code: 0HO1H52958

Class Code: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)

Code: 74G4R6TH13

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

ETHYL ACRYLATE

Code: 71E6178C9T

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

SUCROSE

Code: C151H8M554

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

Active Moieties

DILTIAZEM

Code: EE92BBP03H

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