Febuxostat (Page 9 of 9)

PRINCIPAL DISPLAY PANEL – 40 mg

NDC 0378-3925-93

Febuxostat
Tablets
40 mg

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

Rx only 30 Tablets

Each film-coated tablet contains:
Febuxostat 40 mg

Usual Dosage: See accompanying
prescribing information.

Keep this and all medication out of
the reach of children.

Store at 20° to 25°C (68° to 77°F). [See
USP Controlled Room Temperature.]

Protect from light.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Mylan.com

RMX3925H1

Dispense in a tight, light-resistant
container as defined in the USPusing a child-resistant closure.

Keep container tightly closed.

Code No.: MH/DRUGS/25/NKD/89

Febuxostat Tablets 40 mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 80 mg

NDC 0378-3926-93

Febuxostat
Tablets
80 mg

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

Rx only 30 Tablets

Each film-coated tablet contains:
Febuxostat 80 mg

Usual Dosage: See accompanying
prescribing information.

Keep this and all medication out of
the reach of children.

Store at 20° to 25°C (68° to 77°F). [See
USP Controlled Room Temperature.]

Protect from light.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Mylan.com

RMX3926H1

Dispense in a tight, light-resistant
container as defined in the USPusing a child-resistant closure.

Keep container tightly closed.

Code No.: MH/DRUGS/25/NKD/89

Febuxostat Tablets 80 mg Bottle Label
(click image for full-size original)
FEBUXOSTAT febuxostat tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-3925
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FEBUXOSTAT (FEBUXOSTAT) FEBUXOSTAT 40 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSPOVIDONE (15 MPA.S AT 5%)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code M;FX1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-3925-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0378-3925-77 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:0378-3925-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205385 07/01/2019
FEBUXOSTAT febuxostat tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-3926
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FEBUXOSTAT (FEBUXOSTAT) FEBUXOSTAT 80 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
CROSPOVIDONE (15 MPA.S AT 5%)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL Size 15mm
Flavor Imprint Code M;FX2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-3926-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0378-3926-77 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
3 NDC:0378-3926-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205385 07/01/2019
Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 03/2019 Mylan Pharmaceuticals Inc.

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