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United States · US · US:24979-710_72be83ed-81a8-4d5d-abf9-9154e481d840

Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound)

Orange BookUNIISPLATC L01CD01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerUpsher-Smith Laboratories, LLC
CountryUS (United States)
ATC codeL01CD01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 0

No packs registered.

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": {
    "59906bd2-8337-4cd8-9288-65b90eac2a7a": {
      "match": "brand_token",
      "title": "PACLITAXEL INJECTION [BLUEPOINT LABORATORIES]",
      "spl_version": "2",
      "published_date": "2026-05-25"
    }
  },
  "productid": "24979-710_72be83ed-81a8-4d5d-abf9-9154e481d840",
  "productndc": "24979-710",
  "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": "Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound)",
  "active_ingred_unit": "mg/20mL",
  "application_number": "NDA021660",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Paclitaxel",
  "start_marketing_date": "20220401",
  "active_numerator_strength": "100"
}

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