NDC Code(s) : 50090-1338-0
Packager : A-S Medication Solutions

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TRAMADOL HYDROCHLORIDEtramadol hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-1338(NDC:49884-821)
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 HYDROCHLORIDE100 mg
Inactive Ingredients
Ingredient Name Strength
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
ETHYLCELLULOSE (100 MPA.S)(UNII: 47MLB0F1MV)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POLYVINYL ALCOHOL (100000 MW)(UNII: 949E52Z6MY)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND (convex) Size 6 mm
Flavor Imprint Code Par821
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50090-1338-030 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product28/11/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078783 06/28/2012 10/31/2017

PRINCIPAL DISPLAY PANEL

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