Micafungin

Product NDC: 70594-036
11-digit product format: 705940036
Labeler code: 70594
Product ID: 70594-036_8914e314-98a8-4461-8b86-2fe36b41f9ce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Micafungin Sodium
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Xellia Pharmaceuticals USA LLC
Application: ANDA211713
Marketing category: ANDA
Marketing start: 2021-06-02
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: 2022-12-31
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	70594-036		D	Discontinued by firm		2026-08-11
excluded package	package	70594-036	70594-036-01	D	Discontinued by firm		2026-08-11

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A211713-001	MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2021-06-02
A211713-002	MICAFUNGIN SODIUM	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2021-06-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211713-001	AP
A211713-002	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 · 66 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
2026-02-19 14:30 UTC	2026-02	A211713-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211713-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211713-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211713-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211713-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211713-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211713-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211713-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211713-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211713-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211713-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211713-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211713-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211713-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211713-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211713-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211713-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211713-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211713-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211713-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211713-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211713-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211713-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211713-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211713-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211713-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211713-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211713-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211713-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211713-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211713-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211713-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211713-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211713-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211713-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211713-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211713-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211713-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211713-001	MICAFUNGIN SODIUM	EQ 50MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211713-002	MICAFUNGIN SODIUM	EQ 100MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2021-06-02	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211713-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211713-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211713-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211713-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211713-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211713-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211713-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211713-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211713-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211713-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211713-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211713-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211713-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211713-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211713-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211713-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211713-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211713-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211713-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211713-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211713-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211713-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211713-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211713-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211713-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211713-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211713-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211713-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211713-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211713-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211713-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211713-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211713-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211713-002	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211713-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211713-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211713-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211713-002	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211713-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211713-002	AP	1	`6a51e52b5d6a…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70594-036-01	2021-06-11	C162847	48780-1	ba0f9c33-3408-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use MICAFUNGIN FOR INJECTION safely and effectively. See full prescribing information for MICAFUNGIN FOR INJECTION. MICAFUNGIN for Injection, for intravenous infusion only Initial U.S. Approval: 2005
70594-036-01	2021-01-29	C162847	48780-1	ba0f9c33-3408-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use MICAFUNGIN FOR INJECTION safely and effectively. See full prescribing information for MICAFUNGIN FOR INJECTION. MICAFUNGIN for Injection, for intravenous infusion only Initial U.S. Approval: 2005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70594-036-01	EA - Each	70594-036	c909dc08-4235-4ec3-a248-3bb34bdfc265	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70594-036	MICAFUNGIN (MICAFUNGIN SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC]	13	Legacy NDC	20231201_3bc8668e-8ec3-4c54-b46b-5ca0dac87c1b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
IS1UP79R56	MICAFUNGIN SODIUM	208538-73-2	MICAFUNGIN SODIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70594-036-01	70594003601	1 VIAL, GLASS in 1 CARTON (70594-036-01) > 5 mL in 1 VIAL, GLASS	2021-06-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Micafungin	Xellia Pharmaceuticals USA LLC \| Pharma Packaging Solutions, LLC (Tjoapack, LLC)	2022-07-25	HUMAN PRESCRIPTION DRUG LABEL	13