Prescription Drug Information: Nabumetone (Page 5 of 5)

PRINCIPAL DISPLAY PANEL

Nabumetone 500 mg
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Nabumetone 500 mg

Nabumetone 750 mg
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Nabumetone 750 mg

NABUMETONE
nabumetone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63874-607(NDC:0904-5939)
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
D&C YELLOW NO. 10
HYPROMELLOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POLYSORBATE 80
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW (Light Yellow) Score no score
Shape OVAL Size 15mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63874-607-30 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:63874-607-60 60 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:63874-607-90 90 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
4 NDC:63874-607-01 100 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076009 01/01/2010
NABUMETONE
nabumetone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63874-687(NDC:0904-5940)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NABUMETONE (NABUMETONE) NABUMETONE 750 mg
Inactive Ingredients
Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE
D&C YELLOW NO. 10
HYPROMELLOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POLYSORBATE 80
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
Product Characteristics
Color YELLOW (Dark Yellow) Score no score
Shape OVAL Size 19mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63874-687-30 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:63874-687-60 60 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:63874-687-90 90 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
4 NDC:63874-687-01 100 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076009 01/01/2010
Labeler — Altura Pharmaceuticals, Inc. (006890545)
Establishment
Name Address ID/FEI Operations
Altura Pharmaceuticals, Inc. 006890545 repack, relabel

Revised: 04/2010 Altura Pharmaceuticals, Inc.

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