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United States · US · US:25021-255_5f3284c1-d03f-4fca-bb78-1ead3280af60

Paclitaxel

Orange BookUNIISPLATC L01CD01

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

Identification

ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeL01CD01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    2502125505
    1 VIAL in 1 CARTON (25021-255-05) / 5 mL in 1 VIAL
  • ndc11
    2502125517
    1 VIAL in 1 CARTON (25021-255-17) / 16.7 mL in 1 VIAL
  • ndc11
    2502125550
    1 VIAL in 1 CARTON (25021-255-50) / 50 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
P88XT4IS4D
PACLITAXEL
RxCUI 56946
Orange Book
A207326
AP
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": "25021-255_5f3284c1-d03f-4fca-bb78-1ead3280af60",
  "productndc": "25021-255",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "207326",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "6MG/ML",
        "product_no": "001",
        "approval_date": "Aug 23, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PACLITAXEL",
  "proprietary_name": "Paclitaxel",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA207326",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Paclitaxel",
  "start_marketing_date": "20240201",
  "active_numerator_strength": "6"
}

Related drugs

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