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United States · US · US:65219-570_aaff61c4-203b-4905-9138-0f98959ad013

Bumetanide

In shortageOrange BookUNIISPLATC C03CA02

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeC03CA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6521957004
    10 VIAL, SINGLE-DOSE in 1 CARTON (65219-570-04) / 4 mL in 1 VIAL, SINGLE-DOSE (65219-570-01)

Annotations

UNII (FDA Substance ID)
0Y2S3XUQ5H
BUMETANIDE
RxCUI 1808
Orange Book
A216434
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Bumetanide Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "0Y2S3XUQ5H",
    "rxcui": "1808",
    "inchikey": "MAEIEVLCKWDQJH-UHFFFAOYSA-N",
    "display_name": "BUMETANIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "551918e1-96c4-453a-870c-61b282882206": {
      "match": "brand_token",
      "title": "BUMETANIDE TABLET [NORTHSTAR RX LLC]",
      "spl_version": "1",
      "published_date": "2026-06-02"
    }
  },
  "productid": "65219-570_aaff61c4-203b-4905-9138-0f98959ad013",
  "productndc": "65219-570",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "216434",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.25MG/ML",
        "product_no": "001",
        "approval_date": "May 26, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUMETANIDE",
  "shortage_reason": "Bumetanide Injection",
  "shortage_status": "current",
  "proprietary_name": "Bumetanide",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA216434",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bumetanide",
  "start_marketing_date": "20220926",
  "active_numerator_strength": ".25"
}

Related drugs

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