bendamustine hydrochloride

Orange BookUNIISPLATC L01AA09

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

Identification

ManufacturerAccord Healthcare, Inc.

CountryUS (United States)

ATC codeL01AA09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1672925003
1 VIAL, SINGLE-DOSE in 1 CARTON (16729-250-03) / 5 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

981Y8SX18M

BENDAMUSTINE HYDROCHLORIDE

RxCUI 1114693

Orange Book

A205574

APAP

DailyMed SPL labels

1 version tracked

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",
  "spl_meta": {
    "f359e7c6-d104-457d-a7fe-597c74440353": {
      "match": "brand_token",
      "title": "BENDAMUSTINE HYDROCHLORIDE INJECTION [AVYXA PHARMA, LLC]",
      "spl_version": "1",
      "published_date": "2026-05-29"
    }
  },
  "productid": "16729-250_1d8759d2-4d4d-78ee-e063-6294a90a53ae",
  "productndc": "16729-250",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "205574",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "25MG/VIAL",
        "product_no": "001",
        "approval_date": "Dec 7, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/VIAL",
        "product_no": "002",
        "approval_date": "Dec 7, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BENDAMUSTINE HYDROCHLORIDE",
  "proprietary_name": "bendamustine hydrochloride",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA205574",
  "marketing_category": "ANDA",
  "nonproprietary_name": "bendamustine hydrochloride",
  "start_marketing_date": "20221207",
  "active_numerator_strength": "25"
}

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