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United States · US · US:0517-4300_5db1c7ab-35c2-4764-b1ae-33f44560883b
PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND
Orange BookUNIISPLATC L01CD01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmerican Regent, Inc.
CountryUS (United States)
ATC codeL01CD01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1105174300011 VIAL in 1 CARTON (0517-4300-01) / 20 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
P88XT4IS4D
PACLITAXEL
RxCUI 56946
Orange Book
N211875
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "P88XT4IS4D",
"rxcui": "56946",
"inchikey": "RCINICONZNJXQF-MZXODVADSA-N",
"display_name": "PACLITAXEL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"59906bd2-8337-4cd8-9288-65b90eac2a7a": {
"match": "brand_token",
"title": "PACLITAXEL INJECTION [BLUEPOINT LABORATORIES]",
"spl_version": "2",
"published_date": "2026-05-25"
}
},
"productid": "0517-4300_5db1c7ab-35c2-4764-b1ae-33f44560883b",
"productndc": "0517-4300",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION",
"orange_book": {
"appl_no": "211875",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "100MG/VIAL",
"product_no": "001",
"approval_date": "Jul 27, 2022"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PACLITAXEL",
"proprietary_name": "PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND",
"active_ingred_unit": "mg/20mL",
"application_number": "NDA211875",
"marketing_category": "NDA",
"nonproprietary_name": "Paclitaxel",
"start_marketing_date": "20230502",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code L01CD01.
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