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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

  • ndc11
    6881713450
    1 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

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