NDC Code(s) : 55289-895-15, 55289-895-20, 55289-895-30, 55289-895-60
Packager : PD-Rx Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Tramadol Hydrochloride and AcetaminophenTramadol Hydrochloride and Acetaminophen TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55289-895(NDC:65162-617)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRAMADOL HYDROCHLORIDE(UNII: 9N7R477WCK)
(TRAMADOL - UNII:39J1LGJ30J) 		TRAMADOL HYDROCHLORIDE37.5 mg
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX(UNII: R12CBM0EIZ)
CROSPOVIDONE(UNII: 2S7830E561)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
POVIDONE(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) Score no score
Shape CAPSULE (Biconvex) Size 16 mm
Flavor Imprint Code AN;617
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55289-895-1515 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product16/07/2014
2NDC:55289-895-2020 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product16/07/2014
3NDC:55289-895-3030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product16/07/2014
4NDC:55289-895-6060 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product16/07/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090485 12/17/2009

PRINCIPAL DISPLAY PANEL

55289895 label