PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
Propoxyphene Napsylate and Acetaminophen Tablets
Approved
Approval ID
aaccfdf4-ce07-4799-9a7c-14dc0588a2a3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 20, 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.
propoxyphene napsylate and acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67296-0105
Application NumberANDA075738
Product Classification
M
Marketing Category
C73584
G
Generic Name
propoxyphene napsylate and acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateJune 20, 2011
FDA Product Classification
INGREDIENTS (17)
ACETAMINOPHENActive
Quantity: 650 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
PROPOXYPHENE NAPSYLATEActive
Quantity: 100 mg in 1 1
Code: 38M219L1OJ
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT