Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Unit Dose Services
Unit Dose Services
831995316
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydrocodone Bitartrate and Acetaminophen
Product Details
NDC Product Code
50436-2612Application Number
ANDA040148Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 15, 2017MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
HydrocodoneActive
Code: NO70W886KKClass: ACTIBQuantity: 10 mg in 1 1
AcetaminophenActive
Code: 362O9ITL9DClass: ACTIBQuantity: 325 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Hydrocodone Bitartrate and Acetaminophen
Product Details
NDC Product Code
50436-2605Application Number
ANDA040148Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 15, 2017HydrocodoneActive
Code: NO70W886KKClass: ACTIBQuantity: 7.5 mg in 1 1
AcetaminophenActive
Code: 362O9ITL9DClass: ACTIBQuantity: 325 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Hydrocodone Bitartrate and Acetaminophen
Product Details
NDC Product Code
50436-2171Application Number
ANDA040148Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 15, 2017HydrocodoneActive
Code: NO70W886KKClass: ACTIBQuantity: 2.5 mg in 1 1
AcetaminophenActive
Code: 362O9ITL9DClass: ACTIBQuantity: 325 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT