Diclofenac Sodium Misoprostol

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

75834-265

Application Number

ANDA205143

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 25, 2022

Ingredients

MisoprostolActive

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

DiclofenacActive

Code: QTG126297QClass: ACTIBQuantity: 75 mg in 1 1

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8JClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

CARNAUBA WAXInactive

Code: R12CBM0EIZClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT