Voriconazole (Page 12 of 12)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL- 50 mg Bottle Label

NDC 27241-062-03

30 Tablets

Voriconazole Tablets

50 mg

Rx Onlyajanta

50mg
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 200 mg Bottle Label

NDC 27241-063-03

30 Tablets

Voriconazole Tablets
200 mg
Rx Onlyajanta

200mg
(click image for full-size original)

VORICONAZOLE voriconazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27241-062
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
lactose monohydrate
povidone, unspecified
croscarmellose sodium
magnesium stearate
hypromellose 2910 (15 MPA.S)
titanium dioxide
triacetin
starch, corn
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code V50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:27241-062-03 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206181 05/31/2016
VORICONAZOLE voriconazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:27241-063
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
lactose monohydrate
povidone, unspecified
croscarmellose sodium
magnesium stearate
hypromellose 2910 (15 MPA.S)
titanium dioxide
triacetin
starch, corn
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 16mm
Flavor Imprint Code V200
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:27241-063-03 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206181 05/31/2016
Labeler — Ajanta Pharma USA Inc. (557554156)
Registrant — Ajanta Pharma Limited (918594859)
Establishment
Name Address ID/FEI Operations
Ajanta Pharma Limited 918594859 MANUFACTURE (27241-062), MANUFACTURE (27241-063)

Revised: 11/2022 Ajanta Pharma USA Inc.

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