TRAMADOL HYDROCHLORIDE (Page 11 of 11)

PRINCIPAL DISPLAY PANEL — 50 mg Tablet Bottle Label

Rx Only
NDC 69543-136-11

TraMADOL Hydrochloride
Tablets, USP

C IV

50 mg

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

VIRTUS®
PHARMACEUTICALS

1000 Tablets

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: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:69543-136-10 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:69543-136-50 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:69543-136-11 1000 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 — Virtus Pharmaceuticals LLC (079659493)
Establishment
Name Address ID/FEI Operations
CSPC OUYI Pharmaceutical Co 421303775 MANUFACTURE (69543-136)

Revised: 10/2019 Virtus Pharmaceuticals LLC

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