MICAFUNGIN injection, powder, lyophilized, for solution

Micafungin by

Drug Labeling and Warnings

Micafungin by is a Prescription medication manufactured, distributed, or labeled by Zydus Lifesciences Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

MICAFUNGIN 
micafungin injection, powder, lyophilized, for solution

Product 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: 70771-1683-6	10 in 1 CARTON	04/10/2023
1		5 mL in 1 VIAL; Type 0: Not a Combination Product
2	NDC: 70771-1683-1	1 in 1 CARTON	08/20/2024
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 solution

Product 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: 70771-1684-6	10 in 1 CARTON	04/10/2023
1		5 mL in 1 VIAL; Type 0: Not a Combination Product
2	NDC: 70771-1684-1	1 in 1 CARTON	08/20/2024
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)