Hydrocodone Bitartrate and Acetaminophen
Tablets
Approved
Approval ID
94ba2279-440e-4eaf-ad19-04d90a5c4c10
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 22, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
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 Code71335-2115
Application NumberANDA211487
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 30, 2020
Generic NameHydrocodone Bitartrate and Acetaminophen
INGREDIENTS (8)
HYDROCODONE BITARTRATEActive
Quantity: 7.5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT