Micafungin in Sodium Chloride

Product NDC: 0338-9053
Requested package NDC: 0338-9053-12
11-digit product format: 003389053
Labeler code: 0338
Product ID: 0338-9053_c4a06712-4236-4c33-b5ae-77db633e8303
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: 2026-12-31
Current FDA listing: Yes

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

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 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216142-002	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 100MG BASE/100ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216142-003	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 150MG BASE/150ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216142-001	MICAFUNGIN IN SODIUM CHLORIDE 0.9%	EQ 50MG BASE/50ML (EQ 1MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`8072bd15b7f6…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
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…`

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
IS1UP79R56	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2667650	Internal RxNorm lookup
2667652	Internal RxNorm lookup
2667653	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a95f901e-0ac4-4ec0-9720-9c6a066cd06c	Available on FDA.report

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

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 in Sodium Chloride	MICAFUNGIN IN SODIUM CHLORIDE	Baxter Healthcare Corporation	a95f901e-0ac4-4ec0-9720-9c6a066cd06c	2023-09-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216142 application number: NDA216142 ndc (package): 0338-9053-12 ndc (product): 0338-9053 ndc11 (package): 00338905312

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
0338-9053-12	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	5