Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bryant Ranch Prepack
171714327
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Details
NDC Product Code
63629-1185Application Number
ANDA211610Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 19, 2023MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
AcetaminophenActive
Code: 362O9ITL9DClass: ACTIBQuantity: 300 mg in 1 1
CROSPOVIDONEInactive
Code: 2S7830E561Class: IACT
CodeineActive
Code: GSL05Y1MN6Class: ACTIBQuantity: 15 mg in 1 1