Tramadol hydrochloride and acetaminophen tablet

Ingredients and appearance - Product information

Tramadol hydrochloride and acetaminophen tablet- Tramadol hydrochloride and acetaminophen

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 60760-053
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Tramadol hydrochloride ( UNII: 9N7R477WCK)( Tramadol - UNII: 39J1LGJ30J ) 37.5 mgin 1
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 325 mgin 1

Inactive Ingredients

Ingredient Name Code
Carnauba wax ( UNII: R12CBM0EIZ)
Crospovidone ( UNII: 68401960MK)
Ferrosoferric oxide ( UNII: XM0M87F357)
Ferric oxide red ( UNII: 1K09F3G675)
Ferric oxide yellow ( UNII: EX438O2MRT)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Starch, corn ( UNII: O8232NY3SJ)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Polyvinyl alcohol ( UNII: 532B59J990)
Povidone, unspecified ( UNII: FZ989GH94E)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Stearic acid ( UNII: 4ELV7Z65AP)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color brown (Beige) Imprint Code AN;617
Score 1 Shape CAPSULE (Biconvex)
Size 16 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 60760-053-20 20 in 1 BOTTLE 2009/12/17

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA090485 USA 2009/12/17

Labeler - St. Mary's Medical Park Pharmacy( 063050751)

Establishment

Name ID/FEI Business Operations
St. Mary's Medical Park Pharmacy 063050751 repack( 60760-053), relabel( 60760-053)