Hydrocodone Bitartrate and Acetaminophen
Approved
Approval ID
4db32036-15bc-4ea0-9d0f-4760111a4462
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 13, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
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 Code42549-653
Application NumberANDA040148
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateApril 13, 2012
Generic NameHydrocodone Bitartrate and Acetaminophen
INGREDIENTS (11)
HYDROCODONE BITARTRATEActive
Quantity: 10 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 500 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT