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United States · US · US:69097-398_7dcacda6-4a5c-4840-8f8d-cbf7b30f3415
Paclitaxel protein-bound particles
Orange BookUNIISPLATC L01CD01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCipla USA Inc.
CountryUS (United States)
ATC codeL01CD01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169097398781 VIAL, SINGLE-DOSE in 1 CARTON (69097-398-78) / 20 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
P88XT4IS4D
PACLITAXEL
RxCUI 56946
Orange Book
A209657
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": "69097-398_7dcacda6-4a5c-4840-8f8d-cbf7b30f3415",
"productndc": "69097-398",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION",
"orange_book": {
"appl_no": "209657",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG/VIAL",
"product_no": "001",
"approval_date": "Apr 10, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PACLITAXEL",
"proprietary_name": "Paclitaxel protein-bound particles",
"active_ingred_unit": "mg/20mL",
"application_number": "ANDA209657",
"marketing_category": "ANDA",
"nonproprietary_name": "Paclitaxel protein-bound particles",
"start_marketing_date": "20250415",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code L01CD01.
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