FDA.reportPublic FDA data

NDC 58181-3041-05 - Gleostine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
58181-3041
Requested NDC
58181-3041-05
Package NDCs from labels
58181-3041-5, 58181-3041-05
Manufacturer
NextSource Biotechnology, LLC
Effective date
2024-01-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Gleostine - NextSource Biotechnology, LLCNextSource Biotechnology, LLC2024-01-23HUMAN PRESCRIPTION DRUG LABEL

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 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 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

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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
LomustineLOMUSTINEWilshire Pharmaceuticals, Inc.3c3637fc-4499-4331-a3c4-6969fc86704e2026-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA017588
rxcui: 197896
rxcui: 197894
rxcui: 197895
unii: 7BRF0Z81KG
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
LOMUSTINELOMUSTINECarnegie Pharmaceuticals LLC916dfac8-da11-40e4-9e44-a909e29a6b5f2025-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197896
rxcui: 197894
rxcui: 197895
unii: 7BRF0Z81KG
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
GleostineLOMUSTINEAzurity Pharmaceuticals, Inc.3529fe2f-3c23-4862-bb20-b480269570822025-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA017588
rxcui: 1545776
rxcui: 1545778
rxcui: 1545780
rxcui: 197896
rxcui: 197894
rxcui: 197895
unii: 7BRF0Z81KG
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
GleostineLOMUSTINENextSource Biotechnology, LLC7f77526b-4c40-409c-82ea-d0f934d89cc22024-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA017588
ndc (package): 58181-3042-5
ndc (package): 58181-3041-5
ndc (package): 58181-3040-5
ndc (product): 58181-3040
ndc (product): 58181-3042
ndc (product): 58181-3041
ndc11 (package): 58181304105
rxcui: 1545776
rxcui: 1545778
rxcui: 1545780
rxcui: 197896
rxcui: 197894
rxcui: 197895
spl id: 0fa10522-2034-c417-e063-6394a90a2cf5
spl set id: 7f77526b-4c40-409c-82ea-d0f934d89cc2
unii: 7BRF0Z81KG
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.