HYDROCODONE BITARTRATE AND ACETAMINOPHEN
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CIII
Approved
Approval ID
a1e69243-a744-4746-a574-58b0c167b11c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 29, 2010
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-113
Application NumberANDA089160
Product Classification
M
Marketing Category
C73584
G
Generic Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Specifications
Route of AdministrationORAL
Effective DateJune 29, 2010
FDA Product Classification
INGREDIENTS (9)
HYDROCODONE BITARTRATeActive
Quantity: 5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ACETAMINOPHENActive
Quantity: 500 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT