AmBisome

Product NDC: 0469-3051
11-digit product format: 004693051
Labeler code: 0469
Product ID: 0469-3051_1369d969-91c2-42dc-b8c5-27e8703a2b68
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amphotericin B
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Astellas Pharma US, Inc.
Application: NDA050740
Marketing category: NDA
Marketing start: 1997-08-11
Substance: AMPHOTERICIN B
Active strength: 50 mg/12.5mL
Pharmacologic classes: Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	0469-3051		I	Inactivated by FDA		2026-08-17
excluded package	package	0469-3051	0469-3051-30	I	Inactivated by FDA		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050740-001	AMBISOME	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050740-001	AB

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	1997-08-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	1997-08-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	1997-08-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	1997-08-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	1997-08-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	1997-08-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	1997-08-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	1997-08-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION		RLD, RS	1997-08-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050740-001	AMBISOME	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	RLD, RS	1997-08-11	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N050740-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050740-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050740-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050740-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050740-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050740-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050740-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050740-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050740-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050740-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050740-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050740-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050740-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050740-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050740-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050740-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050740-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050740-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N050740-001	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050740-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050740-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050740-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050740-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050740-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050740-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050740-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050740-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050740-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050740-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050740-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050740-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050740-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N050740-001	AB	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1a09ca27-c656-4f0b-83f8-43751bb90896	Product name	3	20260316
0021efff-57f3-bc98-886c-681a25ca5df1	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0469-3051-30	AmBisome	12.5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	12.5		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0469-3051-30	EA - Each	0469-3051	fd2b18db-ee7b-4a99-91df-4ce75444e321	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
AMPHOTERICIN B	ACTIVE INGREDIENT	7XU7A7DROE	AMBISOME (AMPHOTERICIN B) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASTELLAS PHARMA US, INC.]	4
AMPHOTERICIN B	ACTIVE MOIETY	7XU7A7DROE	AMBISOME (AMPHOTERICIN B) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASTELLAS PHARMA US, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0469-3051	AMBISOME (AMPHOTERICIN B) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ASTELLAS PHARMA US, INC.]	12	Current NDC, Legacy NDC, 1 package rows	20241116_f7be6506-4d20-401e-a0ff-02ad7c33158a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7XU7A7DROE	AMPHOTERICIN B	1397-89-3	AMPHOTERICIN B

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
967388	AmBisome 50 MG Injection	PSN	f7be6506-4d20-401e-a0ff-02ad7c33158a	13
967385	amphotericin B liposomal 50 MG Injection	PSN	f7be6506-4d20-401e-a0ff-02ad7c33158a	13
967388	amphotericin B liposomal 50 MG Injection [AmBisome]	SBD	f7be6506-4d20-401e-a0ff-02ad7c33158a	13
967385	amphotericin B liposomal 50 MG Injection	SCD	f7be6506-4d20-401e-a0ff-02ad7c33158a	13
967388	AmBisome 50 MG Injection	SY	f7be6506-4d20-401e-a0ff-02ad7c33158a	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0469-3051-30	00469305130	12.5 mL in 1 VIAL, SINGLE-DOSE (0469-3051-30)	12.5 ml	1997-08-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AmBisome ® (amphotericin B) liposome for injection	Astellas Pharma US, Inc.	2025-06-11	HUMAN PRESCRIPTION DRUG LABEL	13