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FDA Product

ULTRACET

Product approved by U.S. Food and Drug Administration (US)

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

tramadol hydrochloride

Quantity: 37.5 mg in 1 1

Code: 9N7R477WCK

Class Code: ACTIB

acetaminophen

Quantity: 325 mg in 1 1

Code: 362O9ITL9D

Class Code: ACTIB

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

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