Gleostine

Product NDC: 58181-3042
11-digit product format: 581813042
Labeler code: 58181
Product ID: 58181-3042_0fa10522-2034-c417-e063-6394a90a2cf5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lomustine
Dosage form: CAPSULE, GELATIN COATED
Route: ORAL
Labeler: NextSource Biotechnology, LLC
Application: NDA017588
Marketing category: NDA
Marketing start: 2014-08-18
Substance: LOMUSTINE
Active strength: 100 mg/1
Pharmacologic classes: Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 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 · 168 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	N017588-001	GLEOSTINE	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017588-002	GLEOSTINE	40MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017588-003	GLEOSTINE	100MG	CAPSULE / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017588-004	GLEOSTINE	5MG	CAPSULE / ORAL		RLD	2014-12-19	`caaa826d4ba7…`
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…`

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	N017588-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017588-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017588-003	AB	1	`caaa826d4ba7…`
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: Gleostine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LOMUSTINE	100 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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197894	Internal RxNorm lookup
197895	Internal RxNorm lookup
197896	Internal RxNorm lookup
1545776	Internal RxNorm lookup
1545778	Internal RxNorm lookup
1545780	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
7f77526b-4c40-409c-82ea-d0f934d89cc2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d20364c4-b9df-9129-4e74-fd201b79f7c5	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58181-3042-5	2023-03-29	C162847	48780-1	f386c64a-362f-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use GLEOSTINE safely and effectively. See full prescribing information for GLEOSTINE. GLEOSTINE ® (lomustine) capsules, for oral use Initial U.S. Approval: 1976
58181-3042-5	2023-01-30	C162847	48780-1	f386c64a-362f-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use GLEOSTINE safely and effectively. See full prescribing information for GLEOSTINE. GLEOSTINE ® (lomustine) capsules, for oral use Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58181-3042-5	Gleostine	5 in 1 BOTTLE	CAPSULE, GELATIN COATED	5		15
58181-3042-5	Gleostine	1 in 1 CARTON	CAPSULE, GELATIN COATED	1		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58181-3042-5	EA - Each	58181-3042	aa6f775e-a367-47eb-81c1-023f3fb0e66d	1	2015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
lomustine	ACTIVE INGREDIENT	7BRF0Z81KG	GLEOSTINE (LOMUSTINE) CAPSULE, GELATIN COATED [NEXTSOURCE BIOTECHNOLOGY, LLC]	6
lomustine	ACTIVE MOIETY	7BRF0Z81KG	GLEOSTINE (LOMUSTINE) CAPSULE, GELATIN COATED [NEXTSOURCE BIOTECHNOLOGY, LLC]	6
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	GLEOSTINE (LOMUSTINE) CAPSULE, GELATIN COATED [NEXTSOURCE BIOTECHNOLOGY, LLC]	6
mannitol	INACTIVE INGREDIENT	3OWL53L36A	GLEOSTINE (LOMUSTINE) CAPSULE, GELATIN COATED [NEXTSOURCE BIOTECHNOLOGY, LLC]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58181-3042	GLEOSTINE (LOMUSTINE) CAPSULE, GELATIN COATED [NEXTSOURCE BIOTECHNOLOGY, LLC]	15	Current NDC, Legacy NDC, 2 package rows	20240305_7f77526b-4c40-409c-82ea-d0f934d89cc2.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 · 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
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 ndc (product): 58181-3042

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
1545776	Gleostine 10 MG Oral Capsule	PSN	7f77526b-4c40-409c-82ea-d0f934d89cc2	15
1545778	Gleostine 100 MG Oral Capsule	PSN	7f77526b-4c40-409c-82ea-d0f934d89cc2	15
1545780	Gleostine 40 MG Oral Capsule	PSN	7f77526b-4c40-409c-82ea-d0f934d89cc2	15
197894	lomustine 10 MG Oral Capsule	PSN	7f77526b-4c40-409c-82ea-d0f934d89cc2	15
197895	lomustine 100 MG Oral Capsule	PSN	7f77526b-4c40-409c-82ea-d0f934d89cc2	15
197896	lomustine 40 MG Oral Capsule	PSN	7f77526b-4c40-409c-82ea-d0f934d89cc2	15
1545776	lomustine 10 MG Oral Capsule [Gleostine]	SBD	7f77526b-4c40-409c-82ea-d0f934d89cc2	15
1545778	lomustine 100 MG Oral Capsule [Gleostine]	SBD	7f77526b-4c40-409c-82ea-d0f934d89cc2	15
1545780	lomustine 40 MG Oral Capsule [Gleostine]	SBD	7f77526b-4c40-409c-82ea-d0f934d89cc2	15
197894	lomustine 10 MG Oral Capsule	SCD	7f77526b-4c40-409c-82ea-d0f934d89cc2	15
197895	lomustine 100 MG Oral Capsule	SCD	7f77526b-4c40-409c-82ea-d0f934d89cc2	15
197896	lomustine 40 MG Oral Capsule	SCD	7f77526b-4c40-409c-82ea-d0f934d89cc2	15
1545776	Gleostine 10 MG Oral Capsule	SY	7f77526b-4c40-409c-82ea-d0f934d89cc2	15
1545778	Gleostine 100 MG Oral Capsule	SY	7f77526b-4c40-409c-82ea-d0f934d89cc2	15
1545780	Gleostine 40 MG Oral Capsule	SY	7f77526b-4c40-409c-82ea-d0f934d89cc2	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58181-3042-5	58181304205	1 BOTTLE in 1 CARTON (58181-3042-5) / 5 CAPSULE, GELATIN COATED in 1 BOTTLE	1 bottle	2014-08-18	0000-00-00	No	No	Current