Diclofenac Sodium and Misoprostol

Manufacturing Establishments1

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

Actavis Laboratories FL, Inc.

Labeler

BluePoint Laboratories

DUNS Number

020778751

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

68001-231

Application Number

ANDA201089

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

April 21, 2023

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

HYDROGENATED CASTOR OILInactive

Code: ZF94AP8MEYClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8JClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

DiclofenacActive

Code: QTG126297QClass: ACTIBQuantity: 50 mg in 1 1

MisoprostolActive

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