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United States · US · US:68817-134_d1c7770f-7099-4ad3-84e2-20e638cb224e
ABRAXANE
Orange BookUNIISPLATC L01CD01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAbraxis BioScience, LLC
CountryUS (United States)
ATC codeL01CD01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168817134501 VIAL, SINGLE-USE in 1 CARTON (68817-134-50) / 20 mL in 1 VIAL, SINGLE-USE
Annotations
UNII (FDA Substance ID)
P88XT4IS4D
PACLITAXEL
RxCUI 56946
Orange Book
N021660
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": {
"24d10449-2936-4cd3-b7db-a7683db721e4": {
"match": "brand_token",
"title": "ABRAXANE (PACLITAXEL) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [ABRAXIS BIOSCIENCE, LLC]",
"spl_version": "37",
"published_date": "2026-04-06"
}
},
"productid": "68817-134_d1c7770f-7099-4ad3-84e2-20e638cb224e",
"productndc": "68817-134",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION",
"orange_book": {
"appl_no": "021660",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "100MG/VIAL",
"product_no": "001",
"approval_date": "Jan 7, 2005"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PACLITAXEL",
"proprietary_name": "ABRAXANE",
"active_ingred_unit": "mg/20mL",
"application_number": "NDA021660",
"marketing_category": "NDA",
"nonproprietary_name": "Paclitaxel",
"start_marketing_date": "20050210",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code L01CD01.
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