ACETAMINOPHEN AND CODEINE

Manufacturing Establishments (1)

Labeler

DIRECT RX

DUNS Number

079254320

NDC Product Code

61919-023

Application Number

ANDA040779

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

March 29, 2023

Ingredients

CROSPOVIDONEInactive

Code: 68401960MKClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5XClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

Code: 362O9ITL9DClass: ACTIBQuantity: 300 mg in 1 1

Code: GSL05Y1MN6Class: ACTIBQuantity: 30 mg in 1 1