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United States · US · US:0480-3290_2fbc2699-cf99-497c-94b9-8a2c534c061f
Paclitaxel
Orange BookUNIISPLATC L01CD01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTeva Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL01CD01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1104803290011 VIAL, SINGLE-DOSE in 1 CARTON (0480-3290-01) / 20 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
P88XT4IS4D
PACLITAXEL
RxCUI 56946
Orange Book
N216338
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": "0480-3290_2fbc2699-cf99-497c-94b9-8a2c534c061f",
"productndc": "0480-3290",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION",
"orange_book": {
"appl_no": "216338",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "100MG/VIAL",
"product_no": "001",
"approval_date": "May 11, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PACLITAXEL",
"proprietary_name": "Paclitaxel",
"active_ingred_unit": "mg/20mL",
"application_number": "NDA216338",
"marketing_category": "NDA",
"nonproprietary_name": "Paclitaxel",
"start_marketing_date": "20240702",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code L01CD01.
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