Gleostine

Orange BookUNIISPLATC L01AD02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerNextSource Biotechnology, LLC

CountryUS (United States)

ATC codeL01AD02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5818130405
1 BOTTLE in 1 CARTON (58181-3040-5) / 5 CAPSULE, GELATIN COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

7BRF0Z81KG

LOMUSTINE

RxCUI 6466

Orange Book

N017588

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "7BRF0Z81KG",
    "rxcui": "6466",
    "inchikey": "GQYIWUVLTXOXAJ-UHFFFAOYSA-N",
    "display_name": "LOMUSTINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "3529fe2f-3c23-4862-bb20-b48026957082": {
      "match": "brand_token",
      "title": "GLEOSTINE (LOMUSTINE) CAPSULE, GELATIN COATED [AZURITY PHARMACEUTICALS, INC.]",
      "spl_version": "1",
      "published_date": "2025-11-17"
    }
  },
  "productid": "58181-3040_0fa10522-2034-c417-e063-6394a90a2cf5",
  "productndc": "58181-3040",
  "dosage_form": "CAPSULE, GELATIN COATED",
  "orange_book": {
    "appl_no": "017588",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG",
        "product_no": "004",
        "approval_date": "Dec 19, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LOMUSTINE",
  "proprietary_name": "Gleostine",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA017588",
  "marketing_category": "NDA",
  "nonproprietary_name": "lomustine",
  "start_marketing_date": "20140818",
  "active_numerator_strength": "10"
}

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