Micafungin for Injection, for intravenous use

Manufacturer: Zydus Lifesciences Limited
Effective date: 2025-12-22
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 21:52:20

Label at a glance#

ProductMicafungin

Active ingredientMICAFUNGIN SODIUM

Label structure1 sections

Label contents#

Full prescribing information#

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
861383	micafungin sodium 100 MG Injection	PSN	3
861379	micafungin sodium 50 MG Injection	PSN	3
861383	micafungin 100 MG Injection	SCD	3
861379	micafungin 50 MG Injection	SCD	3
861383	micafungin 100 MG (equivalent to micafungin sodium 101.73 MG) Injection	SY	3
861379	micafungin 50 MG (equivalent to micafungin sodium 50.86 MG) Injection	SY	3

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
MICAFUNGIN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
04f262d4-f446-4cf7-b4fa-28b038cd7ee4	Product name	7	20260113
9c331f34-aa42-465c-8abd-4e929fba4e94	Product name	1	20250625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70771-1683-1	Micafungin	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1	3
70771-1683-1	Micafungin	5 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	5	3
70771-1683-6	Micafungin	5 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	5	3
70771-1683-6	Micafungin	10 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	10	3
70771-1684-1	Micafungin	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1	3
70771-1684-1	Micafungin	5 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	5	3
70771-1684-6	Micafungin	10 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	10	3
70771-1684-6	Micafungin	5 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	5	3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

Micafungin
MICAFUNGIN SODIUM
LACTOSE MONOHYDRATE
ANHYDROUS CITRIC ACID
SODIUM HYDROXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1683	70771-1683-6, 70771-1683-1
70771-1684	70771-1684-6, 70771-1684-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MICAFUNGIN SODIUM	IS1UP79R56	ACTIM
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
MICAFUNGIN SODIUM	IS1UP79R56	ACTIM
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A215241-001	MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2022-10-24
A215241-002	MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2022-10-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A215241-001	AP
A215241-002	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A215241-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215241-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215241-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215241-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215241-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215241-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215241-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215241-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215241-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215241-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215241-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215241-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215241-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215241-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215241-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215241-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215241-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215241-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215241-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215241-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215241-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215241-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215241-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215241-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215241-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215241-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215241-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215241-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215241-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215241-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215241-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215241-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215241-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215241-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215241-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215241-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215241-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215241-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215241-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215241-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-24	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A215241-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215241-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215241-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215241-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215241-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215241-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215241-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215241-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215241-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215241-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215241-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215241-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215241-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215241-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215241-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215241-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215241-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215241-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215241-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215241-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215241-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215241-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215241-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215241-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215241-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215241-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215241-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215241-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215241-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215241-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215241-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215241-002	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215241-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215241-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215241-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A215241-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215241-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A215241-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215241-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215241-002	AP	1	`a72a2bbeb626…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Micafungin	MICAFUNGIN	Zydus Lifesciences Limited	72bc5dd6-6052-4483-9b13-afdeaaa8cc69	2025-12-22		Exact identifier ndc (package): 70771-1684-1 ndc (package): 70771-1683-6 ndc (package): 70771-1684-6 ndc (package): 70771-1683-1 ndc (product): 70771-1684 ndc (product): 70771-1683 ndc11 (package): 70771168401 ndc11 (package): 70771168301 ndc11 (package): 70771168406 ndc11 (package): 70771168306 spl id: 6d0bfa2b-cc2e-4759-988c-543631badfa4 spl set id: 72bc5dd6-6052-4483-9b13-afdeaaa8cc69

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.