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United States · US · US:70121-1743_0aa120d1-67cb-4be7-8884-d716d8b2b8ab
Nelarabine
Orange BookUNIISPLATC L01BB07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeL01BB07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1170121174311 VIAL, SINGLE-DOSE in 1 CARTON (70121-1743-1) / 50 mL in 1 VIAL, SINGLE-DOSE
- ndc1170121174346 VIAL, SINGLE-DOSE in 1 CARTON (70121-1743-4) / 50 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
60158CV180
NELARABINE
RxCUI 274771
Orange Book
A216346
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": "70121-1743_0aa120d1-67cb-4be7-8884-d716d8b2b8ab",
"productndc": "70121-1743",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "216346",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "250MG/50ML (5MG/ML)",
"product_no": "001",
"approval_date": "Apr 4, 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": "ANDA216346",
"marketing_category": "ANDA",
"nonproprietary_name": "Nelarabine",
"start_marketing_date": "20230410",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code L01BB07.
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