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United States · US · US:0703-3213_b9386219-32d5-4ac8-ac24-e4ddae63c936

Paclitaxel

Orange BookUNIISPLATC L01CD01

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

Identification

ManufacturerTeva Parenteral Medicines, Inc.
CountryUS (United States)
ATC codeL01CD01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0703321381
    1 VIAL, MULTI-DOSE in 1 CARTON (0703-3213-81) / 5 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
P88XT4IS4D
PACLITAXEL
RxCUI 56946
Orange Book
A075184
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": "0703-3213_b9386219-32d5-4ac8-ac24-e4ddae63c936",
  "productndc": "0703-3213",
  "dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
  "orange_book": {
    "appl_no": "075184",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "6MG/ML",
        "product_no": "001",
        "approval_date": "Jan 25, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PACLITAXEL",
  "proprietary_name": "Paclitaxel",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA075184",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Paclitaxel",
  "start_marketing_date": "20200707",
  "active_numerator_strength": "6"
}

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