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United States · US · US:43598-142_8105c460-afd8-5eec-7857-c2e4e5b89fc3
Nelarabine
Orange BookUNIISPLATC L01BB07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddy's Laboratories, Inc.
CountryUS (United States)
ATC codeL01BB07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1143598142066 VIAL, SINGLE-DOSE in 1 CARTON (43598-142-06) / 50 mL in 1 VIAL, SINGLE-DOSE
- ndc1143598142111 VIAL, SINGLE-DOSE in 1 CARTON (43598-142-11) / 50 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
60158CV180
NELARABINE
RxCUI 274771
Orange Book
A216934
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": "43598-142_8105c460-afd8-5eec-7857-c2e4e5b89fc3",
"productndc": "43598-142",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "216934",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "250MG/50ML (5MG/ML)",
"product_no": "001",
"approval_date": "Dec 23, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NELARABINE",
"proprietary_name": "Nelarabine",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA216934",
"marketing_category": "ANDA",
"nonproprietary_name": "Nelarabine",
"start_marketing_date": "20230109",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code L01BB07.
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