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NDC 50458-659-60 50 mg tramadol Tablet Bottle

Ultram® (tramadol hydrochloride) Tablets – 50 mg are white, capsule-shaped, coated tablet imprinted “Ultram” on one side and “06 59” on the scored side.

Bottles of 100 tablets: NDC 50458-659-60

Dispense in a tight container. Store at 25°C (77°F); excursions permitted to 15 –30°C (59 – 86°F).

Product of Switzerland

Manufactured by:

Janssen Ortho, LLC
Gurabo, Puerto, Rico 00778

Manufactured for:

Janssen Pharmaceuticals, Inc.
Titusville, New Jersey 08560

© Janssen Pharmaceuticals, Inc. 2003
Revised July 2014

PRINCIPAL DISPLAY PANEL – 50 mg Tablet Bottle Label

NDC 50458-659-60

(tramadol HCl tablets)

50 mg


100 tablets

Rx only.


tramadol hydrochloride tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50458-659
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
modified corn starch (1-octenyl succinic anhydride)
magnesium stearate
cellulose, microcrystalline
polyethylene glycols
polysorbate 80
sodium starch glycolate type a potato
titanium dioxide
carnauba wax
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL (capsule-shaped) Size 13mm
Flavor Imprint Code Ultram;06;59
# Item Code Package Description
1 NDC:50458-659-60 100 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020281 03/03/1995
Labeler – Janssen Pharmaceuticals, Inc. (063137772)
Name Address ID/FEI Operations
Janssen Ortho, LLC 805887986 MANUFACTURE(50458-659), ANALYSIS(50458-659)
Name Address ID/FEI Operations
Proto Chemicals AG 480008890 API MANUFACTURE(50458-659)
Revised: 07/2014

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