Voriconazole (Page 14 of 14)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

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Vial Label

NDC 70436-029-80

Voriconazole for Injection

200 mg* per vial

VORICONAZOLE voriconazole injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70436-029
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VORICONAZOLE (VORICONAZOLE) VORICONAZOLE 200 mg
Inactive Ingredients
Ingredient Name Strength
BETADEX SULFOBUTYL ETHER SODIUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70436-029-80 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 BOX None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211661 01/28/2019
Labeler — Slate Run Pharmaceuticals (039452765)
Registrant — Hainan Poly Pharm. Co., Ltd. (654561638)
Establishment
Name Address ID/FEI Operations
Hainan Poly Pharm. Co., Ltd. 654561638 manufacture (70436-029)

Revised: 01/2023 Slate Run Pharmaceuticals

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