Tramadol HCl and Acetaminophen
Tramadol Hydrochloride and Acetaminophen TabletsCIV
Approved
Approval ID
34498c95-abf4-4ff5-8b9d-2e762aab0d20
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 15, 2016
Manufacturers
FDA
Ascend Laboratories, LLC
DUNS: 141250469
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tramadol HCl and Acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67877-322
Application NumberANDA202076
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tramadol HCl and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2016
FDA Product Classification
INGREDIENTS (11)
TRAMADOL HYDROCHLORIDEActive
Quantity: 37.5 mg in 1 1
Code: 9N7R477WCK
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT