TRAMADOL HYDROCHLORIDE (Page 12 of 12)

PRINCIPAL DISPLAY PANEL — 50 mg Tablet Bottle Label

50 mg Tablet Bottle Label
(click image for full-size original)

TRAMADOL HYDROCHLORIDE tramadol hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76420-127(NDC:69543-136)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRAMADOL HYDROCHLORIDE (TRAMADOL) TRAMADOL HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape OVAL Size 10mm
Flavor Imprint Code 101;OUYI
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76420-127-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:76420-127-60 60 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091498 05/22/2015
Labeler — Asclemed USA, Inc. (059888437)
Establishment
Name Address ID/FEI Operations
ASCLEMED USA INC. DBA ENOVACHEM 059888437 repack (76420-127)

Revised: 08/2020 Asclemed USA, Inc.

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