Hydrocodone Bitartrate and Acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
Approved
Approval ID
f83f57cd-0257-4745-8ee0-21dc6dc05063
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 24, 2012
Manufacturers
FDA
Medsource Pharmaceuticals
DUNS: 833685915
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 Code45865-412
Application NumberANDA040754
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone Bitartrate and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2012
FDA Product Classification
INGREDIENTS (9)
HYDROCODONE BITARTRATEActive
Quantity: 7.5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 650 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT