Diclofenac Sodium and Misoprostol

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Amneal Pharmaceuticals, LLC

Labeler

Amneal Pharmaceuticals LLC

DUNS Number

079389286

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

65162-436

Application Number

ANDA203995

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 24, 2021

Ingredients

MisoprostolActive

Code: 0E43V0BB57Class: ACTIBQuantity: 200 ug in 1 1

DiclofenacActive

Code: QTG126297QClass: ACTIBQuantity: 50 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

CROSPOVIDONE (12 MPA.S AT 5%)Inactive

Code: 40UAA97IT9Class: IACT

HYDROGENATED CASTOR OILInactive

Code: ZF94AP8MEYClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2)Inactive

Code: XRK36F13ZZClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT