Febuxostat (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 80 mg

NDC 46708-191-30
Febuxostat Tablets
80 mg
PHARMACIST: Dispense the accompanying
Medication Guide to each patient.
Rx only
30 TabletsAlembic

30 Tablets
(click image for full-size original)
FEBUXOSTAT febuxostat tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-190
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 (90000 WAMW)
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
POLYETHYLENE GLYCOL 3000
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 (Biconvex) Size 9mm
Flavor Imprint Code L440
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-190-30 30 TABLET, COATED in 1 BOTTLE None
2 NDC:46708-190-31 100 TABLET, COATED in 1 BOTTLE None
3 NDC:46708-190-91 1000 TABLET, COATED in 1 BOTTLE None
4 NDC:46708-190-08 80 TABLET, COATED in 1 CARTON None
5 NDC:46708-190-10 100 TABLET, COATED in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205421 07/01/2019
FEBUXOSTAT febuxostat tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-191
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 (90000 WAMW)
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
POLYETHYLENE GLYCOL 3000
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 (Biconvex) Size 14mm
Flavor Imprint Code L441
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-191-30 30 TABLET, COATED in 1 BOTTLE None
2 NDC:46708-191-31 100 TABLET, COATED in 1 BOTTLE None
3 NDC:46708-191-91 1000 TABLET, COATED in 1 BOTTLE None
4 NDC:46708-191-06 60 TABLET, COATED in 1 CARTON None
5 NDC:46708-191-10 100 TABLET, COATED in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205421 07/01/2019
Labeler — Alembic Pharmaceuticals Limited (650574663)
Establishment
Name Address ID/FEI Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE (46708-190), MANUFACTURE (46708-191)

Revised: 07/2019 Alembic Pharmaceuticals Limited

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