ULORIC (Page 6 of 6)

PRINCIPAL DISPLAY PANEL — 40 mg Tablet Bottle Label

NDC 64764-918-30
30 Tablets

Uloric
(febuxostat)
tablets

40 mg

Dispense the accompanyingMedication Guide to each patient.

PRINCIPAL DISPLAY PANEL -- 40 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 80 mg Tablet Bottle Label

NDC 64764-677-30
30 Tablets

Uloric
(febuxostat)
tablets

80 mg

Dispense the accompanyingMedication Guide to each patient.

PRINCIPAL DISPLAY PANEL -- 80 mg Tablet Bottle Label
(click image for full-size original)
ULORIC febuxostat tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64764-918
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
lactose monohydrate
MICROCRYSTALLINE CELLULOSE
HYDROXYPROPYL CELLULOSE (70000 WAMW)
croscarmellose sodium
silicon dioxide
magnesium stearate
POLYVINYL ALCOHOL, UNSPECIFIED
Talc
POLYETHYLENE GLYCOL, UNSPECIFIED
Titanium Dioxide
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
Product Characteristics
Color GREEN (light green to green) Score no score
Shape ROUND (round shaped) Size 9mm
Flavor Imprint Code TAP;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64764-918-30 30 TABLET in 1 BOTTLE None
2 NDC:64764-918-90 90 TABLET in 1 BOTTLE None
3 NDC:64764-918-18 500 TABLET in 1 BOTTLE None
4 NDC:64764-918-11 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (64764-918-11)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021856 02/13/2009
ULORIC febuxostat tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64764-677
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
lactose monohydrate
MICROCRYSTALLINE CELLULOSE
HYDROXYPROPYL CELLULOSE (70000 WAMW)
croscarmellose sodium
silicon dioxide
magnesium stearate
POLYVINYL ALCOHOL, UNSPECIFIED
Talc
POLYETHYLENE GLYCOL, UNSPECIFIED
Titanium Dioxide
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
Product Characteristics
Color GREEN (light green to green) Score no score
Shape TEAR (teardrop shaped) Size 14mm
Flavor Imprint Code TAP;80
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64764-677-30 30 TABLET in 1 BOTTLE None
2 NDC:64764-677-13 100 TABLET in 1 BOTTLE None
3 NDC:64764-677-19 1000 TABLET in 1 BOTTLE None
4 NDC:64764-677-11 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (64764-677-11)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021856 02/13/2009
Labeler — Takeda Pharmaceuticals America, Inc. (039997266)

Revised: 04/2023 Takeda Pharmaceuticals America, Inc.

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