Amphotericin B

Product NDC: 62756-233
11-digit product format: 627560233
Labeler code: 62756
Product ID: 62756-233_98d535d7-ba62-47e6-825a-2e7d2d8fc564
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amphotericin B
Dosage form: INJECTABLE, LIPOSOMAL
Route: INTRAVENOUS
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA212514
Marketing category: ANDA
Marketing start: 2022-02-09
Substance: AMPHOTERICIN B
Active strength: 50 mg/1
Pharmacologic classes: Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [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 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
A212514-001	AMPHOTERICIN B	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB		2021-12-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212514-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212514-001	AMPHOTERICIN B	50MG/VIAL	INJECTABLE, LIPOSOMAL / INJECTION	AB	2021-12-14	`a50c72e98297…`

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	A212514-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212514-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212514-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212514-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212514-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212514-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212514-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212514-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212514-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212514-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212514-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212514-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212514-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212514-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212514-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212514-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212514-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212514-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212514-001	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212514-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212514-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212514-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212514-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212514-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212514-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212514-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212514-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212514-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212514-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212514-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212514-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212514-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212514-001	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212514-001	CGT	2022-08-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212514-001	CGT	2022-08-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212514-001	CGT	2022-08-14	`4b0b4de00fa7…`
2023-01-26 05:58 UTC	2023-01	A212514-001	CGT	2022-08-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212514-001	CGT	2022-08-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212514-001	CGT	2022-08-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212514-001	CGT	2022-08-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212514-001	CGT	2022-08-14	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Amphotericin B
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMPHOTERICIN B	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7XU7A7DROE	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
967385	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
593cffa0-c305-48b6-8ec7-331e0ff91d2b	Available on FDA.report

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	SPL version
62756-233-01	Amphotericin B	1 in 1 CARTON	INJECTABLE, LIPOSOMAL	1	4
62756-233-01	Amphotericin B	1 in 1 VIAL, SINGLE-DOSE	INJECTABLE, LIPOSOMAL	1	4
62756-233-02	Amphotericin B	1 in 1 CARTON	INJECTABLE, LIPOSOMAL	1	4
62756-233-02	Amphotericin B	10 in 1 CARTON	INJECTABLE, LIPOSOMAL	10	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62756-233-01	EA - Each	62756-233	81df1644-2faa-4c43-a10e-bff4f945f01b	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62756-233	AMPHOTERICIN B INJECTABLE, LIPOSOMAL [SUN PHARMACEUTICAL INDUSTRIES, INC.]	3	Current NDC, Legacy NDC, 4 package rows	20241215_593cffa0-c305-48b6-8ec7-331e0ff91d2b.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amphotericin B	AMPHOTERICIN B	Sun Pharmaceutical Industries, Inc.	02aadef1-390b-4270-b56d-33452eb89dde	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212514 application number: ANDA212514
Amphotericin B	AMPHOTERICIN B	Sun Pharmaceutical Industries, Inc.	593cffa0-c305-48b6-8ec7-331e0ff91d2b	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212514 application number: ANDA212514 ndc (product): 62756-233

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
967385	amphotericin B liposomal 50 MG Injection	PSN	593cffa0-c305-48b6-8ec7-331e0ff91d2b	4
967385	amphotericin B liposomal 50 MG Injection	SCD	593cffa0-c305-48b6-8ec7-331e0ff91d2b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62756-233-01	62756023301	1 VIAL, SINGLE-DOSE in 1 CARTON (62756-233-01) / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE		2022-02-09	0000-00-00	No	No	Current
62756-233-02	62756023302	10 CARTON in 1 CARTON (62756-233-02) / 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE	10 carton	2022-02-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amphotericin B Liposome for Injection Rx only	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited (formerly known as Sun Pharmaceutical Medicare Limited)	2026-04-20	Human Prescription Drug Label	4