Nabumetone (Page 7 of 7)

Package/Label Display Panel

Impax Generics

NDC 0115-1657 -01

NABUMETONE
Tablets USP
500 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only100 TABLETS

Container Label -- 500 mg, 100 ct.
(click image for full-size original)

Package/Label Display Panel

Impax Generics

NDC 0115-1658 -01

NABUMETONE
Tablets USP
750 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only100 TABLETS

Container Label -- 750 mg -- 100 Ct.
(click image for full-size original)
NABUMETONE nabumetone tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-1657
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
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
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 18mm
Flavor Imprint Code 93;15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0115-1657-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0115-1657-03 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075189 08/20/2001
NABUMETONE nabumetone tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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:0115-1658-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0115-1658-03 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075189 09/26/2001
Labeler — Amneal Pharmaceuticals of New York LLC (123797875)

Revised: 04/2019 Amneal Pharmaceuticals of New York LLC

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