Propoxyphene and Acetaminophen
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP50 mg/325 mg and 100 mg/650 mg
Approved
Approval ID
6ce33ae0-8f55-4d74-9c1e-003be1001596
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 3, 2010
Manufacturers
FDA
Keltman Pharmaceuticals Inc.
DUNS: 362861077
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 Code68387-100
Application NumberANDA074843
Product Classification
M
Marketing Category
C73584
G
Generic Name
propoxyphene napsylate and acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateAugust 3, 2010
FDA Product Classification
INGREDIENTS (11)
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ACETAMINOPHENActive
Quantity: 650 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
PROPOXYPHENE NAPSYLATEActive
Quantity: 100 mg in 1 1
Code: 38M219L1OJ
Classification: ACTIB
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT