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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
- ndc11807256102525 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"
}Related drugs
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- 🇪🇸CLORAMBUCILO ASPEN 2 MG COMPRIMIDOS RECUBIERTOS CON PELICULAAspen Pharma Trading Limited
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