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United States · US · US:67184-0593_b392cf53-2b1f-46b5-86dc-c0df49f16730

Bumetanide

In shortageOrange BookUNIISPLATC C03CA02

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

Identification

ManufacturerQilu Pharmaceutical Co., Ltd.
CountryUS (United States)
ATC codeC03CA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6718405932
    10 VIAL in 1 CARTON (67184-0593-2) / 4 mL in 1 VIAL (67184-0593-1)

Annotations

UNII (FDA Substance ID)
0Y2S3XUQ5H
BUMETANIDE
RxCUI 1808
Orange Book
A219116
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": "67184-0593_b392cf53-2b1f-46b5-86dc-c0df49f16730",
  "productndc": "67184-0593",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "219116",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.25MG/ML",
        "product_no": "001",
        "approval_date": "Sep 19, 2024"
      }
    ],
    "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": "ANDA219116",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bumetanide",
  "start_marketing_date": "20240919",
  "active_numerator_strength": ".25"
}

Related drugs

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