Voriconazole (Page 12 of 12)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 72578-062-06 in bottles of 30 tablets

Voriconazole Tablets, 50 mg

30 Tablets

Rx only

figure
(click image for full-size original)

NDC 72578-063-06 in bottles of 30 tablets

Voriconazole Tablets, 200 mg

30 Tablets

Rx only

figure
(click image for full-size original)
VORICONAZOLE voriconazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72578-062
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VORICONAZOLE (VORICONAZOLE) VORICONAZOLE 50 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
POVIDONE K30
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 735
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72578-062-06 30 TABLET in 1 BOTTLE None
2 NDC:72578-062-16 90 TABLET in 1 BOTTLE None
3 NDC:72578-062-01 100 TABLET in 1 BOTTLE None
4 NDC:72578-062-05 500 TABLET in 1 BOTTLE None
5 NDC:72578-062-10 1000 TABLET in 1 BOTTLE None
6 NDC:72578-062-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (72578-062-30)
6 NDC:72578-062-30 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (72578-062-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206747 04/16/2019
VORICONAZOLE voriconazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72578-063
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VORICONAZOLE (VORICONAZOLE) VORICONAZOLE 200 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
POVIDONE K30
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL Size 16mm
Flavor Imprint Code 736
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72578-063-06 30 TABLET in 1 BOTTLE None
2 NDC:72578-063-16 90 TABLET in 1 BOTTLE None
3 NDC:72578-063-01 100 TABLET in 1 BOTTLE None
4 NDC:72578-063-05 500 TABLET in 1 BOTTLE None
5 NDC:72578-063-10 1000 TABLET in 1 BOTTLE None
6 NDC:72578-063-77 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (72578-063-30)
6 NDC:72578-063-30 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (72578-063-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206747 04/16/2019
Labeler — Viona Pharmaceuticals Inc (081468959)
Registrant — Zydus Lifesciences Limited (650199482)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 677605858 ANALYSIS (72578-062), ANALYSIS (72578-063), MANUFACTURE (72578-062), MANUFACTURE (72578-063)

Revised: 11/2022 Viona Pharmaceuticals Inc

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