BUSULFEX

Product NDC: 59148-070
11-digit product format: 591480070
Labeler code: 59148
Product ID: 59148-070_b281d2c1-122c-4a27-8a27-e222359c0fb9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: busulfan
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Otsuka America Pharmaceutical, Inc.
Application: NDA020954
Marketing category: NDA
Marketing start: 1999-02-04
Substance: BUSULFAN
Active strength: 6 mg/mL
Pharmacologic classes: Alkylating Activity [MoA], Alkylating Drug [EPC]
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	59148-070		I	Inactivated by FDA		2026-08-11
excluded package	package	59148-070	59148-070-91	I	Inactivated by FDA		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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020954-001	BUSULFEX	BUSULFAN	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020954-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020954-001	BUSULFEX	6MG/ML	INJECTABLE / INJECTION	AP	RLD, RS	1999-02-04	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	N020954-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020954-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020954-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020954-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020954-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020954-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020954-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020954-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020954-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020954-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020954-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020954-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020954-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020954-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020954-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020954-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020954-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020954-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020954-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020954-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020954-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020954-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020954-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020954-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020954-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020954-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020954-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020954-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020954-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020954-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020954-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020954-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020954-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020954-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020954-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020954-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020954-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020954-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020954-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020954-001	AP	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5cd205af-1b5a-44f8-d007-fc9f5ee3cd5d	Product name	9	20210518
0bcaeed6-5866-1c9f-3423-7db0fa4d0985	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59148-070-91	2021-09-23	C162847	48780-1	c7ccaba7-2526-fd44-e053-dadaa90aa01b	These highlights do not include all the information needed to use BUSULFEX ® safely and effectively. See full prescribing information for BUSULFEX. BUSULFEX (busulfan) Injection, for intravenous use Initial U.S. Approval: 1999
59148-070-91	2021-07-23	C162847	48780-1	c7ccaba7-2526-fd44-e053-dadaa90aa01b	These highlights do not include all the information needed to use BUSULFEX ® safely and effectively. See full prescribing information for BUSULFEX. BUSULFEX (busulfan) Injection, for intravenous use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59148-070-90	BUSULFEX	10 mL in 1 VIAL	INJECTION	10	32
59148-070-90	BUSULFEX	1 in 1 CARTON	INJECTION	1	32
59148-070-91	BUSULFEX	8 in 1 CARTON	INJECTION	8	32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59148-070-90	ML - Milliliter	59148-070	d3bcdc54-7e58-45d7-b97a-61a6eaeac920	1	2012-07-24
59148-070-91	ML - Milliliter	59148-070	6f9b9747-3a3c-4c03-9494-ce69ef1772f1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Busulfan	ACTIVE INGREDIENT	G1LN9045DK	BUSULFEX (BUSULFAN) INJECTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]	14
Busulfan	ACTIVE MOIETY	G1LN9045DK	BUSULFEX (BUSULFAN) INJECTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]	14
N,N-dimethylacetamide	INACTIVE INGREDIENT	JCV5VDB3HY	BUSULFEX (BUSULFAN) INJECTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]	14
Polyethylene Glycol 400	INACTIVE INGREDIENT	B697894SGQ	BUSULFEX (BUSULFAN) INJECTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]	14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59148-070	BUSULFEX (BUSULFAN) INJECTION [OTSUKA AMERICA PHARMACEUTICAL, INC.]	31	Current NDC, Legacy NDC, 3 package rows	20231216_5cb9d285-1803-4a99-946a-d0b239b32df6.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G1LN9045DK	BUSULFAN	55-98-1	BUSULFAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
253113	busulfan 60 MG in 10 ML Injection	PSN	5cb9d285-1803-4a99-946a-d0b239b32df6	32
284425	Busulfex 60 MG in 10 ML Injection	PSN	5cb9d285-1803-4a99-946a-d0b239b32df6	32
284425	10 ML busulfan 6 MG/ML Injection [Busulfex]	SBD	5cb9d285-1803-4a99-946a-d0b239b32df6	32
253113	10 ML busulfan 6 MG/ML Injection	SCD	5cb9d285-1803-4a99-946a-d0b239b32df6	32
284425	10 ML Busulfex 6 MG/ML Injection	SY	5cb9d285-1803-4a99-946a-d0b239b32df6	32
253113	busulfan 60 MG per 10 ML Injection	SY	5cb9d285-1803-4a99-946a-d0b239b32df6	32
284425	Busulfex 60 MG per 10 ML Injection	SY	5cb9d285-1803-4a99-946a-d0b239b32df6	32

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59148-070-90	59148007090	10 mL in 1 VIAL	10 ml					Historical
59148-070-91	59148007091	8 CARTON in 1 CARTON (59148-070-91) / 1 VIAL in 1 CARTON (59148-070-90) / 10 mL in 1 VIAL	8 carton	1999-02-04	0000-00-00	No	No	Current