Nabumetone: Package Insert and Label Information (Page 4 of 4)

Package/Label Display Panel

NABUMETONE
Tablets USP
750 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

image
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NABUMETONE
nabumetone tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-859(NDC:0115-1658)
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
SILICON DIOXIDE
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (5 MPA.S)
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 6000
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color brown (beige) Score no score
Shape OVAL Size 20mm
Flavor Imprint Code 93;16
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43063-859-40 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075189 09/26/2001
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (43063-859)

Revised: 06/2020 PD-Rx Pharmaceuticals, Inc.

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