NDC Code(s) : 50090-0919-4, 50090-0919-1, 50090-0919-2, 50090-0919-3, 50090-0919-0
Packager : A-S Medication Solutions

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:50090-0919(NDC:53746-617)
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 (12 MPA.S AT 5%)(UNII: 40UAA97IT9)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(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) 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:50090-0919-490 in 1 BOTTLE Type 0: Not a Combination Product07/08/2014
2NDC:50090-0919-130 in 1 BOTTLE Type 0: Not a Combination Product28/11/2014
3NDC:50090-0919-260 in 1 BOTTLE Type 0: Not a Combination Product28/11/2014
4NDC:50090-0919-3120 in 1 BOTTLE Type 0: Not a Combination Product14/07/2015
5NDC:50090-0919-020 in 1 BOTTLE Type 0: Not a Combination Product28/11/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090485 12/17/2009

LABELER - A-S Medication Solutions(830016429)

Establishment
Name Address ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL(50090-0919), REPACK(50090-0919)

PRINCIPAL DISPLAY PANEL

Label Image