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United States · US · US:80725-610_5a3f7aed-1747-4c52-9e10-5aa090dd088e

LEUKERAN

Orange BookUNIISPLATC L01AA02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerWaylis Therapeutics LLC
CountryUS (United States)
ATC codeL01AA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8072561025
    25 TABLET, FILM COATED in 1 BOTTLE (80725-610-25)

Annotations

UNII (FDA Substance ID)
18D0SL7309
CHLORAMBUCIL
RxCUI 2346
Orange Book
N010669
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "18D0SL7309",
    "rxcui": "2346",
    "inchikey": "JCKYGMPEJWAADB-UHFFFAOYSA-N",
    "display_name": "CHLORAMBUCIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "58a3c995-5ad6-465d-8437-5970c9088213": {
      "match": "brand_token",
      "title": "LEUKERAN (CHLORAMBUCIL) TABLET, FILM COATED [WAYLIS THERAPEUTICS LLC]",
      "spl_version": "2",
      "published_date": "2025-01-10"
    }
  },
  "productid": "80725-610_5a3f7aed-1747-4c52-9e10-5aa090dd088e",
  "productndc": "80725-610",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "010669",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CHLORAMBUCIL",
  "proprietary_name": "LEUKERAN",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA010669",
  "marketing_category": "NDA",
  "nonproprietary_name": "chlorambucil",
  "start_marketing_date": "20230515",
  "active_numerator_strength": "2"
}

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