LOMUSTINE

Orange BookUNIISPLATC L01AD02

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

Identification

ManufacturerCarnegie Pharmaceuticals LLC

CountryUS (United States)

ATC codeL01AD02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8000511602
5 CAPSULE in 1 BOTTLE (80005-116-02)

Annotations

UNII (FDA Substance ID)

7BRF0Z81KG

LOMUSTINE

RxCUI 6466

Orange Book

A219265

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": {
    "3c3637fc-4499-4331-a3c4-6969fc86704e": {
      "match": "brand_token",
      "title": "LOMUSTINE CAPSULE, GELATIN COATED [WILSHIRE PHARMACEUTICALS, INC.]",
      "spl_version": "2",
      "published_date": "2026-04-15"
    }
  },
  "productid": "80005-116_42672c94-b4e6-4bb8-b6b4-7c429acd7ea2",
  "productndc": "80005-116",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "219265",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Oct 27, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "Oct 27, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Oct 27, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LOMUSTINE",
  "proprietary_name": "LOMUSTINE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA219265",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LOMUSTINE",
  "start_marketing_date": "20251110",
  "active_numerator_strength": "100"
}

Related drugs

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