Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Sandhills Packaging
Keltman Pharmaceuticals Inc.
825138717
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tramadol Hydrochloride and Acetaminophen
Product Details
NDC Product Code
68387-497Application Number
ANDA076475Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 20, 2010MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TramadolActive
Code: 9N7R477WCKClass: ACTIBQuantity: 37.5 mg in 1 1
AcetaminophenActive
Code: 362O9ITL9DClass: ACTIBQuantity: 325 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
HYPROMELLOSE 2910 (3 CPS)Inactive
Code: 0VUT3PMY82Class: IACT
HYPROMELLOSE 2910 (6 CPS)Inactive
Code: 0WZ8WG20P6Class: IACT
HYPROMELLOSE 2910 (50 CPS)Inactive
Code: 1IVH67816NClass: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1AClass: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IEClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT