Nabumetone (Page 8 of 8)

PRINCIPAL DISPLAY PANEL

NDC 0591-3670-01

Nabumetone Tablets, USP

500 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only
100 Tablets

500mg100s

PRINCIPAL DISPLAY PANEL

NDC 0591-3671-01

Nabumetone Tablets, USP

750 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only
100 Tablets

NABUMETONE nabumetone tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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 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 Score no score Shape OVAL Size 17mm Flavor Imprint Code 3670 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0591-3670-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None 2 NDC:0591-3670-05 500 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 06/13/2011

NABUMETONE nabumetone tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-3671 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 STARCH, CORN HYPROMELLOSES MAGNESIUM STEARATE POVIDONE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO TITANIUM DIOXIDE TRIACETIN FERRIC OXIDE RED

Product Characteristics Color pink Score no score Shape OVAL Size 19mm Flavor Imprint Code 3671 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0591-3671-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None 2 NDC:0591-3671-05 500 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 06/13/2011

Labeler — Actavis Pharma, Inc. (119723554)

Revised: 02/2022 Actavis Pharma, Inc.