Hydrocodone Bitartrate and Acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
Approved
Approval ID
deaf83c4-6df1-4f11-82cc-9fed561e8b40
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 23, 2012
Manufacturers
FDA
Contract Pharmacy Services-PA
DUNS: 945429777
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 Code67046-927
Application NumberANDA040729
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone Bitartrate and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 23, 2010
FDA Product Classification
INGREDIENTS (5)
HYDROCODONE BITARTRATEActive
Quantity: 5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 500 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT