Basic Information
ULTRACET
54868-4703
Regulatory Information
54868-4703
NDA021123
C73594
August 29, 2012
USA
ULTRACET (tramadol hydrochloride/acetaminophen) Tablets
HUMAN PRESCRIPTION DRUG LABEL
1
Company Information
194123980
Active Ingredients
powdered cellulose
Code: SMD1X3XO9M
Class Code: IACT
starch, corn
Code: O8232NY3SJ
Class Code: IACT
magnesium stearate
Code: 70097M6I30
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
carnauba wax
Code: R12CBM0EIZ
Class Code: IACT
hypromelloses
Code: 3NXW29V3WO
Class Code: IACT
polyethylene glycols
Code: 3WJQ0SDW1A
Class Code: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO
Code: 5856J3G2A2
Class Code: IACT
polysorbate 80
Code: 6OZP39ZG8H
Class Code: IACT
titanium dioxide
Code: 15FIX9V2JP
Class Code: IACT
Active Moieties
tramadol
Code: 39J1LGJ30J
acetaminophen
Code: 362O9ITL9D