TREANDA

Orange BookUNIIATC L01AA09

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerCephalon, LLC

CountryUS (United States)

ATC codeL01AA09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6345939008
1 VIAL, SINGLE-DOSE in 1 CARTON (63459-390-08) / 5 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

981Y8SX18M

BENDAMUSTINE HYDROCHLORIDE

RxCUI 1114693

Orange Book

N022249

APAP

Raw payload (JSON)

{
  "unii": {
    "unii": "981Y8SX18M",
    "rxcui": "1114693",
    "inchikey": "ZHSKUOZOLHMKEA-UHFFFAOYSA-N",
    "display_name": "BENDAMUSTINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "productid": "63459-390_77ae475d-2d59-4fe2-8de7-833b6fc9d51a",
  "productndc": "63459-390",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "022249",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "100MG/VIAL",
        "product_no": "001",
        "approval_date": "Mar 20, 2008"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "25MG/VIAL",
        "product_no": "002",
        "approval_date": "May 1, 2009"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "45MG/0.5ML (90MG/ML)",
        "product_no": "003",
        "approval_date": "Sep 13, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "180MG/2ML (90MG/ML)",
        "product_no": "004",
        "approval_date": "Sep 13, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BENDAMUSTINE HYDROCHLORIDE",
  "proprietary_name": "TREANDA",
  "active_ingred_unit": "mg/5mL",
  "application_number": "NDA022249",
  "marketing_category": "NDA",
  "nonproprietary_name": "Bendamustine Hydrochloride",
  "start_marketing_date": "20100105",
  "active_numerator_strength": "25"
}

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