🇺🇸
United States · US · US:80725-620_da6a0ae8-6165-4e4f-b759-600cd940d252
MYLERAN
In shortageOrange BookUNIISPLATC L01AB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerWaylis Therapeutics LLC
CountryUS (United States)
ATC codeL01AB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11807256202525 TABLET, FILM COATED in 1 BOTTLE (80725-620-25)
Annotations
UNII (FDA Substance ID)
G1LN9045DK
BUSULFAN
RxCUI 1828
Orange Book
N009386
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Busulfan Injection
Raw payload (JSON)
{
"unii": {
"unii": "G1LN9045DK",
"rxcui": "1828",
"inchikey": "COVZYZSDYWQREU-UHFFFAOYSA-N",
"display_name": "BUSULFAN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"2da33e5b-dcfb-4cdf-b163-50398e42f41c": {
"match": "brand_token",
"title": "MYLERAN (BUSULFAN) TABLET, FILM COATED [WAYLIS THERAPEUTICS LLC]",
"spl_version": "2",
"published_date": "2025-01-10"
}
},
"productid": "80725-620_da6a0ae8-6165-4e4f-b759-600cd940d252",
"productndc": "80725-620",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "009386",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "2MG",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BUSULFAN",
"shortage_reason": "Busulfan Injection",
"shortage_status": "current",
"proprietary_name": "MYLERAN",
"active_ingred_unit": "mg/1",
"application_number": "NDA009386",
"marketing_category": "NDA",
"nonproprietary_name": "busulfan",
"start_marketing_date": "20230515",
"active_numerator_strength": "2"
}Related drugs
Other records sharing ATC code L01AB01.
- DKBusilvexPierre Fabre Medicament
- FIBusilvexPierre Fabre Medicament
- BEBusilvex 6 mg/mlPierre Fabre Médicament
- 🇪🇸BUSILVEX 6 mg/ml CONCENTRADO PARA SOLUCION PARA PERFUSIONPierre Fabre Medicament
- 🇫🇷BUSILVEX 6 mg/ml, solution à diluer pour perfusionPIERRE FABRE MEDICAMENT
- GBBusilvex 60mg/10ml concentrate for solution for infusion ampoulesPierre Fabre Ltd
- 🇺🇸BusulfanSagent Pharmaceuticals
- 🇺🇸BusulfanPharmascience Inc.
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