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United States · US · US:81927-375_f21b358e-9f41-4dc3-858f-b55f9a8af715
nelarabine
Orange BookUNIISPLATC L01BB07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerShorla Oncology Inc.
CountryUS (United States)
ATC codeL01BB07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1181927375011 VIAL, SINGLE-DOSE in 1 CARTON (81927-375-01) / 75 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
60158CV180
NELARABINE
RxCUI 274771
Orange Book
A214809
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "60158CV180",
"rxcui": "274771",
"inchikey": "IXOXBSCIXZEQEQ-UHTZMRCNSA-N",
"display_name": "NELARABINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"8d0e1b59-bd1e-4c6e-9a95-e8143ee076bf": {
"match": "brand_token",
"title": "NELARABINE INJECTION [AMNEAL PHARMACEUTICALS LLC]",
"spl_version": "8",
"published_date": "2026-03-31"
}
},
"productid": "81927-375_f21b358e-9f41-4dc3-858f-b55f9a8af715",
"productndc": "81927-375",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "214809",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "250MG/50ML (5MG/ML)",
"product_no": "001",
"approval_date": "Mar 3, 2023"
},
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "375MG/75ML (5MG/ML)",
"product_no": "002",
"approval_date": "Jul 16, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NELARABINE",
"proprietary_name": "nelarabine",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA214809",
"marketing_category": "ANDA",
"nonproprietary_name": "nelarabine",
"start_marketing_date": "20250831",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code L01BB07.
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