MedPath
FDA Product

Diclofenac Sodium

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

Basic Information

Diclofenac Sodium

76420-572

Regulatory Information

76420-572

ANDA090066

C73584

March 6, 2024

USA

Diclofenac Sodium Delayed-release Tablets, USP 25 mg, 50 mg and 75 mg

HUMAN PRESCRIPTION DRUG LABEL

1

Company Information

Asclemed USA, Inc.

059888437

Active Ingredients

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MICROCRYSTALLINE CELLULOSE 101

Code: 7T9FYH5QMK

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

POVIDONE

Code: FZ989GH94E

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A

Code: NX76LV5T8J

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

POLYETHYLENE GLYCOL 6000

Code: 30IQX730WE

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

DICLOFENAC SODIUM

Quantity: 50 mg in 1 1

Code: QTG126297Q

Class Code: ACTIB

Active Moieties

DICLOFENAC

Code: 144O8QL0L1

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