NDC Code(s) : 50090-0531-0, 50090-0531-1, 50090-0531-5
Packager : A-S Medication Solutions

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ULTRAMtramadol hydrochloride TABLET, COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-0531(NDC:50458-659)
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 HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient Name Strength
starch, corn(UNII: O8232NY3SJ)
modified corn starch (1-octenyl succinic anhydride)(UNII: 461P5CJN6T)
hypromellose, unspecified(UNII: 3NXW29V3WO)
lactose, unspecified form(UNII: J2B2A4N98G)
magnesium stearate(UNII: 70097M6I30)
microcrystalline cellulose(UNII: OP1R32D61U)
polyethylene glycol, unspecified(UNII: 3WJQ0SDW1A)
polysorbate 80(UNII: 6OZP39ZG8H)
sodium starch glycolate type a potato(UNII: 5856J3G2A2)
titanium dioxide(UNII: 15FIX9V2JP)
carnauba wax(UNII: R12CBM0EIZ)
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL (capsule-shaped) Size 13 mm
Flavor Imprint Code ULTRAM;06;59
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50090-0531-0 20 in 1 BOTTLE Type 0: Not a Combination Product28/11/2014
2NDC:50090-0531-1 30 in 1 BOTTLE Type 0: Not a Combination Product28/11/2014
3NDC:50090-0531-5 15 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
NDA NDA020281 03/03/1995 02/28/2017

PRINCIPAL DISPLAY PANEL

Label Image