HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Hydrocodone Bitartrate & Acetaminophen Tablets
Approved
Approval ID
30e299ce-ad48-422a-bc00-4cb565390f22
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 9, 2011
Manufacturers
FDA
RedPharm Drug Inc.
DUNS: 008039641
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 Code67296-0470
Application NumberANDA089971
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydrocodone bitartrate and acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateJune 9, 2011
FDA Product Classification
INGREDIENTS (6)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROCODONE BITARTRATEActive
Quantity: 5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ACETAMINOPHENActive
Quantity: 500 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT