Label: MICAFUNGIN injection, powder, lyophilized, for solution
- NDC Code(s): 70771-1683-1, 70771-1683-6, 70771-1684-1, 70771-1684-6
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 21, 2024
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INGREDIENTS AND APPEARANCE
MICAFUNGIN
micafungin injection, powder, lyophilized, for solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1683 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICAFUNGIN SODIUM (UNII: IS1UP79R56) (MICAFUNGIN - UNII:R10H71BSWG) MICAFUNGIN 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SODIUM HYDROXIDE (UNII: 55X04QC32I) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1683-1 1 in 1 CARTON 08/20/2024 1 5 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:70771-1683-6 10 in 1 CARTON 04/10/2023 2 5 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215241 04/10/2023 MICAFUNGIN
micafungin injection, powder, lyophilized, for solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1684 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICAFUNGIN SODIUM (UNII: IS1UP79R56) (MICAFUNGIN - UNII:R10H71BSWG) MICAFUNGIN 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SODIUM HYDROXIDE (UNII: 55X04QC32I) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1684-1 1 in 1 CARTON 08/20/2024 1 5 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:70771-1684-6 10 in 1 CARTON 04/10/2023 2 5 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215241 04/10/2023 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 873671928 MANUFACTURE(70771-1683, 70771-1684) , ANALYSIS(70771-1683, 70771-1684)
