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United States · US · US:70748-323_39d376d9-2fab-40d3-8592-668c5083a0c9

BUMETANIDE

In shortageOrange BookUNIISPLATC C03CA02

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

Identification

ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC03CA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7074832310
    10 VIAL in 1 CARTON (70748-323-10) / 4 mL in 1 VIAL
  • ndc11
    7074832311
    10 VIAL in 1 CARTON (70748-323-11) / 10 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
0Y2S3XUQ5H
BUMETANIDE
RxCUI 1808
Orange Book
A217153
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": "70748-323_39d376d9-2fab-40d3-8592-668c5083a0c9",
  "productndc": "70748-323",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "217153",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.25MG/ML",
        "product_no": "001",
        "approval_date": "Sep 17, 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": "ANDA217153",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bumetanide",
  "start_marketing_date": "20241111",
  "active_numerator_strength": ".25"
}

Related drugs

Other records sharing ATC code C03CA02.

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