ACETAMINOPHEN AND CODEINE PHOSPHATE

Manufacturing Establishments (1)

Labeler

A-S Medication Solutions

DUNS Number

830016429

NDC Product Code

50090-5204

Application Number

ANDA211610

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 20, 2021

Ingredients

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

CROSPOVIDONE, UNSPECIFIEDInactive

Code: 2S7830E561Class: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

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

Code: GSL05Y1MN6Class: ACTIBQuantity: 60 mg in 1 1

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POVIDONE, UNSPECIFIEDInactive

Code: FZ989GH94EClass: IACT