Febuxostat

FEBUXOSTAT- febuxostat tablet
Zydus Lifesciences Limited

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Febuxostat Tablets, 40 mg – 30’s count

NDC- 70771-1552-3

40 mg label
(click image for full-size original)

Febuxostat Tablets, 80 mg – 30’s count

NDC- 70771-1553-3

80 mg label
(click image for full-size original)
FEBUXOSTAT
febuxostat tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1552
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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
SODIUM STEARYL FUMARATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape OVAL (OVAL) Size 13mm
Flavor Imprint Code 401
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1552-3 30 TABLET in 1 BOTTLE None
2 NDC:70771-1552-9 90 TABLET in 1 BOTTLE None
3 NDC:70771-1552-1 100 TABLET in 1 BOTTLE None
4 NDC:70771-1552-5 500 TABLET in 1 BOTTLE None
5 NDC:70771-1552-0 1000 TABLET in 1 BOTTLE None
6 NDC:70771-1552-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
6 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (70771-1552-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205443 03/31/2023
FEBUXOSTAT
febuxostat tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1553
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
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
SODIUM STEARYL FUMARATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 12mm
Flavor Imprint Code 402
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1553-3 30 TABLET in 1 BOTTLE None
2 NDC:70771-1553-9 90 TABLET in 1 BOTTLE None
3 NDC:70771-1553-1 100 TABLET in 1 BOTTLE None
4 NDC:70771-1553-5 500 TABLET in 1 BOTTLE None
5 NDC:70771-1553-0 1000 TABLET in 1 BOTTLE None
6 NDC:70771-1553-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
6 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (70771-1553-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205443 03/31/2023
Labeler — Zydus Lifesciences Limited (918596198)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 918596198 ANALYSIS (70771-1552), ANALYSIS (70771-1553), MANUFACTURE (70771-1552), MANUFACTURE (70771-1553)

Revised: 10/2023 Zydus Lifesciences Limited

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