Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Strides Shasun Limited
Ascend Laboratories, LLC
915786829
Products1
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
NDC Product Code
67877-322Application Number
ANDA202076Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 15, 2016TramadolActive
Code: 9N7R477WCKClass: ACTIBQuantity: 37.5 mg in 1 1
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
AcetaminophenActive
Code: 362O9ITL9DClass: ACTIBQuantity: 325 mg in 1 1
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1AClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT