Micafungin

Product NDC: 42023-229
11-digit product format: 420230229
Labeler code: 42023
Product ID: 42023-229_d1ed890c-2d2e-4e45-bb19-cd0929a17e0b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Micafungin
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Par Pharmaceutical, Inc.
Application: NDA212156
Marketing category: NDA
Marketing start: 2021-08-01
Marketing end: 0000-00-00
Substance: MICAFUNGIN SODIUM
Active strength: 10 mg/mL
Pharmacologic classes: Echinocandin Antifungal [EPC], Lipopeptides [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42023-229		D	Discontinued by firm		2026-10-05
excluded package	package	42023-229	42023-229-10	D	Discontinued by firm		2026-10-05

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
N212156-001	MICAFUNGIN	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS		RLD	2021-06-16
N212156-002	MICAFUNGIN	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS		RLD	2021-06-16

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 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N212156-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212156-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD	2021-06-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212156-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212156-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212156-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212156-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212156-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212156-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212156-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212156-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212156-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212156-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212156-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212156-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212156-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212156-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212156-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212156-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212156-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212156-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212156-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212156-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212156-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212156-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212156-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212156-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212156-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212156-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212156-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212156-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212156-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N212156-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212156-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212156-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212156-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N212156-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212156-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N212156-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212156-001	MICAFUNGIN	EQ 50MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N212156-002	MICAFUNGIN	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2021-06-16	`bb7c543d1eb4…`

Reported adverse events (FAERS/openFDA)#

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

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	Strength	SPL version
42023-229-10	Micafungin	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	10		13
42023-229-10	Micafungin	10 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	10		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42023-229-10	EA - Each	42023-229	7c3b9862-5669-49e9-bf00-874c60d42624	1	2021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42023-229	MICAFUNGIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ENDO USA, INC.]	11	Legacy NDC, 2 package rows	20240915_70b3f044-95ca-4503-b669-ed39972592b6.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
IS1UP79R56	MICAFUNGIN SODIUM	208538-73-2	MICAFUNGIN SODIUM
R10H71BSWG	MICAFUNGIN	235114-32-6	Micafungin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861383	micafungin sodium 100 MG Injection	PSN	70b3f044-95ca-4503-b669-ed39972592b6	13
861379	micafungin sodium 50 MG Injection	PSN	70b3f044-95ca-4503-b669-ed39972592b6	13
861383	micafungin 100 MG Injection	SCD	70b3f044-95ca-4503-b669-ed39972592b6	13
861379	micafungin 50 MG Injection	SCD	70b3f044-95ca-4503-b669-ed39972592b6	13
861383	micafungin 100 MG (equivalent to micafungin sodium 101.73 MG) Injection	SY	70b3f044-95ca-4503-b669-ed39972592b6	13
861379	micafungin 50 MG (equivalent to micafungin sodium 50.86 MG) Injection	SY	70b3f044-95ca-4503-b669-ed39972592b6	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42023-229-10	42023022910	10 VIAL, SINGLE-DOSE in 1 CARTON (42023-229-10) > 10 mL in 1 VIAL, SINGLE-DOSE	2021-08-01	0000-00-00	No	No	Current