gleostine

Generic: lomustine

Labeler: nextsource biotechnology, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name gleostine
Generic Name lomustine
Labeler nextsource biotechnology, llc
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

lomustine 40 mg/1

Manufacturer
NextSource Biotechnology, LLC

Identifiers & Regulatory

Product NDC 58181-3041
Product ID 58181-3041_0fa10522-2034-c417-e063-6394a90a2cf5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA017588
Listing Expiration 2026-12-31
Marketing Start 2014-08-18

Pharmacologic Class

Established (EPC)
alkylating drug [epc]
Mechanism of Action
alkylating activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 581813041
Hyphenated Format 58181-3041

Supplemental Identifiers

RxCUI
197894 197895 197896 1545776 1545778 1545780
UNII
7BRF0Z81KG
NUI
N0000000236 N0000175558

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name gleostine (source: ndc)
Generic Name lomustine (source: ndc)
Application Number NDA017588 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (58181-3041-5) / 5 CAPSULE, GELATIN COATED in 1 BOTTLE
source: ndc

Packages (1)

58181-3041-5 1 BOTTLE in 1 CARTON (58181-3041-5) / 5 CAPSULE, GELATIN COATED in 1 BOTTLE

Ingredients (1)

lomustine (40 mg/1)

Linked Drug Pages (1)

Gleostine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0fa10522-2034-c417-e063-6394a90a2cf5", "openfda": {"nui": ["N0000000236", "N0000175558"], "unii": ["7BRF0Z81KG"], "rxcui": ["197894", "197895", "197896", "1545776", "1545778", "1545780"], "spl_set_id": ["7f77526b-4c40-409c-82ea-d0f934d89cc2"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["NextSource Biotechnology, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (58181-3041-5)  / 5 CAPSULE, GELATIN COATED in 1 BOTTLE", "package_ndc": "58181-3041-5", "marketing_start_date": "20140818"}], "brand_name": "Gleostine", "product_id": "58181-3041_0fa10522-2034-c417-e063-6394a90a2cf5", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "58181-3041", "generic_name": "lomustine", "labeler_name": "NextSource Biotechnology, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gleostine", "active_ingredients": [{"name": "LOMUSTINE", "strength": "40 mg/1"}], "application_number": "NDA017588", "marketing_category": "NDA", "marketing_start_date": "20140818", "listing_expiration_date": "20261231"}