Micafungin in Sodium Chloride

Product NDC: 0338-9053
11-digit product format: 003389053
Labeler code: 0338
Product ID: 0338-9053_54bb3336-4740-4625-807f-24423b45a838
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Micafungin in Sodium Chloride
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Corporation
Application: NDA216142
Marketing category: NDA
Marketing start: 2023-09-29
Substance: MICAFUNGIN SODIUM
Active strength: 100 mg/100mL
Pharmacologic classes: Echinocandin Antifungal [EPC], Lipopeptides [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	MICAFUNGIN SODIUM	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29
N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	MICAFUNGIN SODIUM	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29
N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	MICAFUNGIN SODIUM	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N216142-001	12403173	2037-12-15	Drug product	2025-09-12
N216142-002	12403173	2037-12-15	Drug product	2025-09-12
N216142-003	12403173	2037-12-15	Drug product	2025-09-12

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 · 69 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`79d66fd596c7…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N216142-001	12403173	2037-12-15	Drug product	2025-09-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216142-002	12403173	2037-12-15	Drug product	2025-09-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216142-003	12403173	2037-12-15	Drug product	2025-09-12	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N216142-001	12403173	2037-12-15	Drug product	2025-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216142-002	12403173	2037-12-15	Drug product	2025-09-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216142-003	12403173	2037-12-15	Drug product	2025-09-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216142-001	12403173	2037-12-15	Drug product	2025-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216142-002	12403173	2037-12-15	Drug product	2025-09-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216142-003	12403173	2037-12-15	Drug product	2025-09-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216142-001	12403173	2037-12-15	Drug product	2025-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216142-002	12403173	2037-12-15	Drug product	2025-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216142-003	12403173	2037-12-15	Drug product	2025-09-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216142-001	12403173	2037-12-15	Drug product	2025-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216142-002	12403173	2037-12-15	Drug product	2025-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216142-003	12403173	2037-12-15	Drug product	2025-09-12	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216142-001	12403173	2037-12-15	Drug product	2025-09-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216142-002	12403173	2037-12-15	Drug product	2025-09-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216142-003	12403173	2037-12-15	Drug product	2025-09-12	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Micafungin in Sodium Chloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MICAFUNGIN SODIUM	100 mg/100mL

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
0338-9053-01	Micafungin in Sodium Chloride	1 in 1 CARTON	INJECTION	1	4
0338-9053-01	Micafungin in Sodium Chloride	100 mL in 1 BAG	INJECTION	100	4
0338-9053-12	Micafungin in Sodium Chloride	12 in 1 CARTON	INJECTION	12	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-9053-01	ML - Milliliter	0338-9053	1d7f705f-8a61-44de-afbf-c9a0e11cee8c	1	2024-06-10
0338-9053-12	ML - Milliliter	0338-9053	1042543c-2746-438a-9e37-205a74056722	1	2024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-9053	MICAFUNGIN IN SODIUM CHLORIDE INJECTION [BAXTER HEALTHCARE CORPORATION]	4	Current NDC, 3 package rows	20250501_a95f901e-0ac4-4ec0-9720-9c6a066cd06c.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2667650	micafungin 100 MG in 100 ML Injection	PSN	a95f901e-0ac4-4ec0-9720-9c6a066cd06c	4
2667652	micafungin 150 MG in 150 ML Injection	PSN	a95f901e-0ac4-4ec0-9720-9c6a066cd06c	4
2667653	micafungin 50 MG in 50 ML Injection	PSN	a95f901e-0ac4-4ec0-9720-9c6a066cd06c	4
2667650	100 ML micafungin 1 MG/ML Injection	SCD	a95f901e-0ac4-4ec0-9720-9c6a066cd06c	4
2667652	150 ML micafungin 1 MG/ML Injection	SCD	a95f901e-0ac4-4ec0-9720-9c6a066cd06c	4
2667653	50 ML micafungin 1 MG/ML Injection	SCD	a95f901e-0ac4-4ec0-9720-9c6a066cd06c	4
2667650	micafungin 100 MG (equivalent to micafungin sodium 101.73 MG) per 100 ML Injection	SY	a95f901e-0ac4-4ec0-9720-9c6a066cd06c	4
2667650	micafungin 100 MG per 100 ML Injection	SY	a95f901e-0ac4-4ec0-9720-9c6a066cd06c	4
2667652	micafungin 150 MG (equivalent to micafungin sodium 152.6 MG) per 100 ML Injection	SY	a95f901e-0ac4-4ec0-9720-9c6a066cd06c	4
2667652	micafungin 150 MG per 150 ML Injection	SY	a95f901e-0ac4-4ec0-9720-9c6a066cd06c	4
2667653	micafungin 50 MG (equivalent to micafungin sodium 50.87 MG) per 100 ML Injection	SY	a95f901e-0ac4-4ec0-9720-9c6a066cd06c	4
2667653	micafungin 50 MG per 50 ML Injection	SY	a95f901e-0ac4-4ec0-9720-9c6a066cd06c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0338-9053-01	00338905301	1 in 1 CARTON					Historical
0338-9053-12	00338905312	12 CARTON in 1 CARTON (0338-9053-12) / 1 BAG in 1 CARTON (0338-9053-01) / 100 mL in 1 BAG	12 carton	2023-09-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Micafungin in Sodium Chloride	Baxter Healthcare Corporation	2023-09-29	HUMAN PRESCRIPTION DRUG LABEL	6