NABUMETONE (Page 6 of 6)

PACKAGE LABEL — NABUMETONE 500 MG TABLETS

Nabumetone 500 mg Label Image
(click image for full-size original)

Nabumetone 500 mg Label Image

Relabeling and Repackaging by:
STAT Rx USA LLC
Gainesville, GA 30501

NABUMETONE
nabumetone tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42549-523(NDC:49884-195)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NABUMETONE (NABUMETONE) NABUMETONE 500 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SODIUM LAURYL SULFATE
SILICON DIOXIDE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
HYPROMELLOSES
POLYETHYLENE GLYCOLS
POLYSORBATE 80
Product Characteristics
Color white Score no score
Shape OVAL Size 9mm
Flavor Imprint Code IG;257
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42549-523-60 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078671 03/01/2008
Labeler — STAT Rx USA LLC (786036330)
Registrant — PSS World Medical Inc. (101822682)
Establishment
Name Address ID/FEI Operations
STAT Rx USA LLc 786036330 relabel, repack

Revised: 04/2012 STAT Rx USA LLC

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