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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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