Prescription Drug Information: Nabumetone (Page 5 of 5)

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NDC: 51655-396-25

Label
(click image for full-size original)
NABUMETONE nabumetone tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-396(NDC:69097-965)
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
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
HYPROMELLOSE, UNSPECIFIED
SODIUM LAURYL SULFATE
SILICON DIOXIDE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
Product Characteristics
Color white Score no score
Shape OVAL Size 15mm
Flavor Imprint Code IG;257
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51655-396-25 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078671 07/07/2020
Labeler — Northwind Pharmaceuticals, LLC (036986393)
Registrant — Northwind Pharmaceuticals, LLC (036986393)
Establishment
Name Address ID/FEI Operations
Northwind Pharmaceuticals, LLC 036986393 repack (51655-396)

Revised: 10/2023 Northwind Pharmaceuticals, LLC

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