PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1683-6

Micafungin for Injection

50 mg/vial

For Intravenous Infusion Only

10 x 50 mg Single-Dose Vials

Rx only

NDC 70771-1684-6

Micafungin for Injection

100 mg/vial

For Intravenous Infusion Only

10 x 100 mg Single-Dose Vials

Rx only

MICAFUNGIN
micafungin injection, powder, lyophilized, for solution

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MICAFUNGIN SODIUM (UNII: IS1UP79R56) (MICAFUNGIN - UNII:R10H71BSWG)	MICAFUNGIN SODIUM	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1683-6	10 in 1 CARTON	04/10/2023
1	NDC:70771-1683-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA215241	04/10/2023

MICAFUNGIN
micafungin injection, powder, lyophilized, for solution

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MICAFUNGIN SODIUM (UNII: IS1UP79R56) (MICAFUNGIN - UNII:R10H71BSWG)	MICAFUNGIN SODIUM	20 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1684-6	10 in 1 CARTON	04/10/2023
1	NDC:70771-1684-1	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA215241	04/10/2023

Labeler - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		873671928	MANUFACTURE(70771-1683, 70771-1684) , ANALYSIS(70771-1683, 70771-1684)

Micafungin for Injection, for intravenous use