Lomustine

Product NDC: 52536-341
11-digit product format: 525360341
Labeler code: 52536
Product ID: 52536-341_934ec2f1-8c3f-4978-b712-33e98c4295a5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lomustine
Dosage form: CAPSULE, GELATIN COATED
Route: ORAL
Labeler: Wilshire Pharmaceuticals, Inc.
Application: NDA017588
Marketing category: NDA
Marketing start: 2026-04-15
Substance: LOMUSTINE
Active strength: 40 mg/1
Pharmacologic classes: Alkylating Activity [MoA], Alkylating Drug [EPC]
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 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017588-001	GLEOSTINE	LOMUSTINE	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982
N017588-002	GLEOSTINE	LOMUSTINE	40MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982
N017588-003	GLEOSTINE	LOMUSTINE	100MG	CAPSULE / ORAL	AB	RLD, Approved before 1982
N017588-004	GLEOSTINE	LOMUSTINE	5MG	CAPSULE / ORAL		RLD	2014-12-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N017588-001	AB
N017588-002	AB
N017588-003	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 5 · 164 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	N017588-001	GLEOSTINE	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017588-002	GLEOSTINE	40MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017588-003	GLEOSTINE	100MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017588-004	GLEOSTINE	5MG	CAPSULE / ORAL		RLD	2014-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017588-001	GLEOSTINE	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017588-002	GLEOSTINE	40MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017588-003	GLEOSTINE	100MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017588-004	GLEOSTINE	5MG	CAPSULE / ORAL		RLD	2014-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017588-001	GLEOSTINE	10MG	CAPSULE / ORAL		RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017588-002	GLEOSTINE	40MG	CAPSULE / ORAL		RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017588-003	GLEOSTINE	100MG	CAPSULE / ORAL		RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017588-004	GLEOSTINE	5MG	CAPSULE / ORAL		RLD	2014-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017588-001	GLEOSTINE	10MG	CAPSULE / ORAL		RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017588-002	GLEOSTINE	40MG	CAPSULE / ORAL		RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017588-003	GLEOSTINE	100MG	CAPSULE / ORAL		RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017588-004	GLEOSTINE	5MG	CAPSULE / ORAL		RLD	2014-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017588-001	GLEOSTINE	10MG	CAPSULE / ORAL		RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017588-002	GLEOSTINE	40MG	CAPSULE / ORAL		RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017588-003	GLEOSTINE	100MG	CAPSULE / ORAL		RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017588-004	GLEOSTINE	5MG	CAPSULE / ORAL		RLD	2014-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017588-001	GLEOSTINE	10MG	CAPSULE / ORAL		RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017588-002	GLEOSTINE	40MG	CAPSULE / ORAL		RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017588-003	GLEOSTINE	100MG	CAPSULE / ORAL		RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017588-004	GLEOSTINE	5MG	CAPSULE / ORAL		RLD	2014-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017588-001	GLEOSTINE	10MG	CAPSULE / ORAL		RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017588-002	GLEOSTINE	40MG	CAPSULE / ORAL		RLD, RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017588-003	GLEOSTINE	100MG	CAPSULE / ORAL		RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017588-004	GLEOSTINE	5MG	CAPSULE / ORAL		RLD	2014-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017588-001	GLEOSTINE	10MG	CAPSULE / ORAL		RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017588-002	GLEOSTINE	40MG	CAPSULE / ORAL		RLD, RS, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017588-003	GLEOSTINE	100MG	CAPSULE / ORAL		RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017588-004	GLEOSTINE	5MG	CAPSULE / ORAL		RLD	2014-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017588-001	GLEOSTINE	10MG	CAPSULE / ORAL		RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017588-002	GLEOSTINE	40MG	CAPSULE / ORAL		RLD, RS, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017588-003	GLEOSTINE	100MG	CAPSULE / ORAL		RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017588-004	GLEOSTINE	5MG	CAPSULE / ORAL		RLD	2014-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017588-001	GLEOSTINE	10MG	CAPSULE / ORAL		RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017588-002	GLEOSTINE	40MG	CAPSULE / ORAL		RLD, RS, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017588-003	GLEOSTINE	100MG	CAPSULE / ORAL		RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017588-004	GLEOSTINE	5MG	CAPSULE / ORAL		RLD	2014-12-19	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017588-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017588-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017588-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017588-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017588-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017588-003	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017588-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017588-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017588-003	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LOMUSTINE	40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7BRF0Z81KG	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197894	Internal RxNorm lookup
197895	Internal RxNorm lookup
197896	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
3c3637fc-4499-4331-a3c4-6969fc86704e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
d20364c4-b9df-9129-4e74-fd201b79f7c5	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52536-341-05	Lomustine	5 in 1 BOTTLE	CAPSULE, GELATIN COATED	5		2
52536-341-05	Lomustine	1 in 1 CARTON	CAPSULE, GELATIN COATED	1		2

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lomustine	LOMUSTINE	Wilshire Pharmaceuticals, Inc.	3c3637fc-4499-4331-a3c4-6969fc86704e	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017588 application number: NDA017588 ndc (product): 52536-341
Gleostine	LOMUSTINE	Azurity Pharmaceuticals, Inc.	3529fe2f-3c23-4862-bb20-b48026957082	2025-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017588 application number: NDA017588
Gleostine	LOMUSTINE	NextSource Biotechnology, LLC	7f77526b-4c40-409c-82ea-d0f934d89cc2	2024-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 017588 application number: NDA017588

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7BRF0Z81KG	LOMUSTINE	13010-47-4	LOMUSTINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197894	lomustine 10 MG Oral Capsule	PSN	3c3637fc-4499-4331-a3c4-6969fc86704e	2
197895	lomustine 100 MG Oral Capsule	PSN	3c3637fc-4499-4331-a3c4-6969fc86704e	2
197896	lomustine 40 MG Oral Capsule	PSN	3c3637fc-4499-4331-a3c4-6969fc86704e	2
197894	lomustine 10 MG Oral Capsule	SCD	3c3637fc-4499-4331-a3c4-6969fc86704e	2
197895	lomustine 100 MG Oral Capsule	SCD	3c3637fc-4499-4331-a3c4-6969fc86704e	2
197896	lomustine 40 MG Oral Capsule	SCD	3c3637fc-4499-4331-a3c4-6969fc86704e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
52536-341-05	52536034105	1 BOTTLE in 1 CARTON (52536-341-05) / 5 CAPSULE, GELATIN COATED in 1 BOTTLE	1 bottle	2026-04-15	No	No	Current