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United States · US · US:62332-813_3869e365-aa84-42e8-a307-e84be57588f7
NELARABINE
Orange BookUNIISPLATC L01BB07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeL01BB07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1162332813501 VIAL in 1 CARTON (62332-813-50) / 50 mL in 1 VIAL
- ndc1162332813636 VIAL in 1 CARTON (62332-813-63) / 50 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
60158CV180
NELARABINE
RxCUI 274771
Orange Book
A218554
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": "62332-813_3869e365-aa84-42e8-a307-e84be57588f7",
"productndc": "62332-813",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "218554",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "250MG/50ML (5MG/ML)",
"product_no": "001",
"approval_date": "Aug 1, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NELARABINE",
"proprietary_name": "NELARABINE",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA218554",
"marketing_category": "ANDA",
"nonproprietary_name": "nelarabine",
"start_marketing_date": "20240801",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code L01BB07.
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