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United States · US · US:70710-1726_b3627acf-0207-443a-8e5a-0b4ad974715a
Nelarabine
Orange BookUNIISPLATC L01BB07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeL01BB07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1170710172611 VIAL, SINGLE-DOSE in 1 CARTON (70710-1726-1) / 50 mL in 1 VIAL, SINGLE-DOSE
- ndc1170710172686 VIAL, SINGLE-DOSE in 1 CARTON (70710-1726-8) / 50 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
60158CV180
NELARABINE
RxCUI 274771
Orange Book
A215037
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": "70710-1726_b3627acf-0207-443a-8e5a-0b4ad974715a",
"productndc": "70710-1726",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "215037",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "250MG/50ML (5MG/ML)",
"product_no": "001",
"approval_date": "Nov 17, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NELARABINE",
"proprietary_name": "Nelarabine",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA215037",
"marketing_category": "ANDA",
"nonproprietary_name": "Nelarabine",
"start_marketing_date": "20211117",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code L01BB07.
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