HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Hydrocodone Bitartrate & Acetaminophen Tablets
Approved
Approval ID
9ce3b2bf-fa69-4940-95af-960cc0bb8320
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 10, 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.
ydrocodone bitartrate and acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67296-0719
Application NumberANDA040143
Product Classification
M
Marketing Category
C73584
G
Generic Name
ydrocodone bitartrate and acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateJune 10, 2011
FDA Product Classification
INGREDIENTS (11)
HYDROCODONE BITARTRATEActive
Quantity: 10 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ACETAMINOPHENActive
Quantity: 650 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT