gleostine

Generic: lomustine

Labeler: azurity pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name gleostine
Generic Name lomustine
Labeler azurity pharmaceuticals, inc.
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

lomustine 100 mg/1

Manufacturer
Azurity Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 24338-342
Product ID 24338-342_3529fe2f-3c23-4862-bb20-b48026957082
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA017588
Listing Expiration 2026-12-31
Marketing Start 2025-10-24

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 24338342
Hyphenated Format 24338-342

Supplemental Identifiers

RxCUI
197894 197895 197896 1545776 1545778 1545780
UPC
0324338340059 0324338342053 0324338341056
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
  • 100 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (24338-342-05) / 5 CAPSULE, GELATIN COATED in 1 BOTTLE
source: ndc

Packages (1)

24338-342-05 1 BOTTLE in 1 CARTON (24338-342-05) / 5 CAPSULE, GELATIN COATED in 1 BOTTLE

Ingredients (1)

lomustine (100 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": "3529fe2f-3c23-4862-bb20-b48026957082", "openfda": {"nui": ["N0000000236", "N0000175558"], "upc": ["0324338340059", "0324338342053", "0324338341056"], "unii": ["7BRF0Z81KG"], "rxcui": ["197894", "197895", "197896", "1545776", "1545778", "1545780"], "spl_set_id": ["3529fe2f-3c23-4862-bb20-b48026957082"], "pharm_class_epc": ["Alkylating Drug [EPC]"], "pharm_class_moa": ["Alkylating Activity [MoA]"], "manufacturer_name": ["Azurity Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (24338-342-05)  / 5 CAPSULE, GELATIN COATED in 1 BOTTLE", "package_ndc": "24338-342-05", "marketing_start_date": "20251024"}], "brand_name": "Gleostine", "product_id": "24338-342_3529fe2f-3c23-4862-bb20-b48026957082", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Alkylating Activity [MoA]", "Alkylating Drug [EPC]"], "product_ndc": "24338-342", "generic_name": "lomustine", "labeler_name": "Azurity Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gleostine", "active_ingredients": [{"name": "LOMUSTINE", "strength": "100 mg/1"}], "application_number": "NDA017588", "marketing_category": "NDA", "marketing_start_date": "20251024", "listing_expiration_date": "20261231"}