Nabumetone (Page 7 of 7)

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Nabumetone Tablets, USP 500mg
20 Tablets
NDC 10544-120-20

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NABUMETONE nabumetone tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10544-120(NDC:0591-3670)
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
COLLOIDAL SILICON DIOXIDE
STARCH, CORN
HYPROMELLOSES
MAGNESIUM STEARATE
POVIDONE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
TRIACETIN
TALC
Product Characteristics
Color WHITE (white) Score no score
Shape OVAL (OVAL) Size 17mm
Flavor Imprint Code 3670
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10544-120-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091083 05/22/2013
Labeler — Blenheim Pharmacal, Inc. (171434587)
Registrant — Blenheim Pharmacal, Inc. (171434587)
Establishment
Name Address ID/FEI Operations
Blenheim Pharmacal, Inc. 171434587 repack (10544-120)

Revised: 07/2015 Blenheim Pharmacal, Inc.

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