FDA.reportPublic FDA data

Gleostine

Product NDC
58181-3041
11-digit product format
581813041
Labeler code
58181
Product ID
58181-3041_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
40 mg/1
Pharmacologic classes
Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gleostine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOMUSTINE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7BRF0Z81KG
Rxcui197894, 197895, 197896, 1545776, 1545778, 1545780

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d20364c4-b9df-9129-4e74-fd201b79f7c5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58181-3041-52023-03-29C16284748780-1f386c64a-362f-0266-e053-dadaa90a7c1aThese 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
58181-3041-52023-01-30C16284748780-1f386c64a-362f-0266-e053-dadaa90a7c1aThese 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 NDCProductDescriptionFormQuantityStrengthSPL version
58181-3041-5Gleostine5 in 1 BOTTLECAPSULE, GELATIN COATED515
58181-3041-5Gleostine1 in 1 CARTONCAPSULE, GELATIN COATED115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58181-3041-5EA - Each58181-3041de063962-a1bb-4d59-8af0-7ab57e0a7bac12015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
lomustineACTIVE INGREDIENT7BRF0Z81KGGLEOSTINE (LOMUSTINE) CAPSULE, GELATIN COATED [NEXTSOURCE BIOTECHNOLOGY, LLC]6
lomustineACTIVE MOIETY7BRF0Z81KGGLEOSTINE (LOMUSTINE) CAPSULE, GELATIN COATED [NEXTSOURCE BIOTECHNOLOGY, LLC]6
magnesium stearateINACTIVE INGREDIENT70097M6I30GLEOSTINE (LOMUSTINE) CAPSULE, GELATIN COATED [NEXTSOURCE BIOTECHNOLOGY, LLC]6
mannitolINACTIVE INGREDIENT3OWL53L36AGLEOSTINE (LOMUSTINE) CAPSULE, GELATIN COATED [NEXTSOURCE BIOTECHNOLOGY, LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58181-3041GLEOSTINE (LOMUSTINE) CAPSULE, GELATIN COATED [NEXTSOURCE BIOTECHNOLOGY, LLC]15Current NDC, Legacy NDC, 2 package rows20240305_7f77526b-4c40-409c-82ea-d0f934d89cc2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1545776Gleostine 10 MG Oral CapsulePSN7f77526b-4c40-409c-82ea-d0f934d89cc215
1545778Gleostine 100 MG Oral CapsulePSN7f77526b-4c40-409c-82ea-d0f934d89cc215
1545780Gleostine 40 MG Oral CapsulePSN7f77526b-4c40-409c-82ea-d0f934d89cc215
197894lomustine 10 MG Oral CapsulePSN7f77526b-4c40-409c-82ea-d0f934d89cc215
197895lomustine 100 MG Oral CapsulePSN7f77526b-4c40-409c-82ea-d0f934d89cc215
197896lomustine 40 MG Oral CapsulePSN7f77526b-4c40-409c-82ea-d0f934d89cc215
1545776lomustine 10 MG Oral Capsule [Gleostine]SBD7f77526b-4c40-409c-82ea-d0f934d89cc215
1545778lomustine 100 MG Oral Capsule [Gleostine]SBD7f77526b-4c40-409c-82ea-d0f934d89cc215
1545780lomustine 40 MG Oral Capsule [Gleostine]SBD7f77526b-4c40-409c-82ea-d0f934d89cc215
197894lomustine 10 MG Oral CapsuleSCD7f77526b-4c40-409c-82ea-d0f934d89cc215
197895lomustine 100 MG Oral CapsuleSCD7f77526b-4c40-409c-82ea-d0f934d89cc215
197896lomustine 40 MG Oral CapsuleSCD7f77526b-4c40-409c-82ea-d0f934d89cc215
1545776Gleostine 10 MG Oral CapsuleSY7f77526b-4c40-409c-82ea-d0f934d89cc215
1545778Gleostine 100 MG Oral CapsuleSY7f77526b-4c40-409c-82ea-d0f934d89cc215
1545780Gleostine 40 MG Oral CapsuleSY7f77526b-4c40-409c-82ea-d0f934d89cc215

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58181-3041-5581813041051 BOTTLE in 1 CARTON (58181-3041-5) / 5 CAPSULE, GELATIN COATED in 1 BOTTLE1 bottle2014-08-180000-00-00NoNoCurrent