Micafungin For Injection, For Intravenous Use

SPL v3

SPL

SPL Set ID 72bc5dd6-6052-4483-9b13-afdeaaa8cc69

Route

INTRAVENOUS

Published

Effective Date 2022-11-23

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Micafungin (10 mg)

Inactive Ingredients

Lactose Monohydrate Anhydrous Citric Acid Sodium Hydroxide

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

ANDA Active Since 2023-04-10

Description

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

Medication Information

Description

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

Structured Label Content

Package Label.principal Display Panel (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

Advanced Ingredient Data

[{"name": "MICAFUNGIN", "unii": "R10H71BSWG", "classCode": "ACTIM", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICAFUNGIN", "unii": "R10H71BSWG", "classCode": "ACTIM", "strengthNumerator": "20", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:51:31.059273 · Updated: 2026-03-14T22:40:41.023270