Hydrocodone Bitartrate And Acetaminophen
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CIII Rx only
Approved
Approval ID
4bbf4358-e149-4b21-ab3a-b0c17cc43afc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 14, 2012
Manufacturers
FDA
Life Line Home Care Services, Inc.
DUNS: 844985374
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 Code75921-881
Application NumberANDA089971
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone Bitartrate And Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 14, 2012
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROCODONE BITARTRATEActive
Quantity: 5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 500 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT