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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 200 mg Bottle Label

NDC 27241-063-03

30 Tablets

Voriconazole Tablets
200 mg
Rx Onlyajanta

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.