Voriconazole (Page 12 of 12)

Principal Label Display Panel

NDC 0781-5667-31

Voriconazole Tablets

50 mg

30 Tablets

50-mg
(click image for full-size original)

Principal Display Panel

NDC 0781-5668-31

Voriconazole Tablets

200 mg

30 Tablets

200-mg
(click image for full-size original)

VORICONAZOLE voriconazole tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-5667
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
LACTOSE MONOHYDRATE
STARCH, CORN
CROSCARMELLOSE SODIUM
POVIDONE K30
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE (White to off-white) Score no score
Shape ROUND (biconvex) Size 4mm
Flavor Imprint Code SZ;132
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-5667-31 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0781-5667-05 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:0781-5667-10 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:0781-5667-13 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (0781-5667-06)
4 NDC:0781-5667-06 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0781-5667-13)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200265 12/12/2011
VORICONAZOLE voriconazole tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-5668
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
LACTOSE MONOHYDRATE
STARCH, CORN
CROSCARMELLOSE SODIUM
POVIDONE K30
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE (White to off-white) Score no score
Shape CAPSULE Size 6mm
Flavor Imprint Code SZ;133
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-5668-31 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0781-5668-05 500 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:0781-5668-10 1000 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:0781-5668-13 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (0781-5668-06)
4 NDC:0781-5668-06 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (0781-5668-13)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200265 12/12/2011
Labeler — Sandoz Inc (005387188)

Revised: 10/2022 Sandoz Inc

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