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United States · US · US:72205-154_d556a9e7-310b-41dc-99f8-a281fe7da3fe
NELARABINE
Orange BookUNIISPLATC L01BB07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNovadoz Pharmaceuticals LLC
CountryUS (United States)
ATC codeL01BB07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1172205154011 VIAL in 1 CARTON (72205-154-01) / 50 mL in 1 VIAL
- ndc1172205154046 VIAL in 1 CARTON (72205-154-04) / 50 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
60158CV180
NELARABINE
RxCUI 274771
Orange Book
A216948
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": "72205-154_d556a9e7-310b-41dc-99f8-a281fe7da3fe",
"productndc": "72205-154",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "216948",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "250MG/50ML (5MG/ML)",
"product_no": "001",
"approval_date": "Sep 13, 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": "ANDA216948",
"marketing_category": "ANDA",
"nonproprietary_name": "NELARABINE",
"start_marketing_date": "20240913",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code L01BB07.
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