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United States · US · US:71288-165_6e728854-7685-4806-8edb-e2a3fc055c7d
Nelarabine
Orange BookUNIISPLATC L01BB07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMeitheal Pharmaceuticals Inc
CountryUS (United States)
ATC codeL01BB07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171288165541 VIAL, SINGLE-DOSE in 1 CARTON (71288-165-54) / 50 mL in 1 VIAL, SINGLE-DOSE (71288-165-52)
Annotations
UNII (FDA Substance ID)
60158CV180
NELARABINE
RxCUI 274771
Orange Book
A216038
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": "71288-165_6e728854-7685-4806-8edb-e2a3fc055c7d",
"productndc": "71288-165",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "216038",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "250MG/50ML (5MG/ML)",
"product_no": "001",
"approval_date": "Jan 10, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NELARABINE",
"proprietary_name": "Nelarabine",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA216038",
"marketing_category": "ANDA",
"nonproprietary_name": "Nelarabine",
"start_marketing_date": "20230110",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code L01BB07.
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