Bumetanide

In shortageOrange BookUNIISPLATC C03CA02

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

Identification

ManufacturerExelan Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeC03CA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7628279901
100 TABLET in 1 BOTTLE (76282-799-01)
ndc11
7628279905
500 TABLET in 1 BOTTLE (76282-799-05)

Annotations

UNII (FDA Substance ID)

0Y2S3XUQ5H

BUMETANIDE

RxCUI 1808

Orange Book

A212931

ABABAB

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": "ORAL",
  "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": "76282-799_04a4ac27-f6b7-4a88-899b-93a5a21ddb6e",
  "productndc": "76282-799",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "212931",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Sep 18, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Sep 18, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2MG",
        "product_no": "003",
        "approval_date": "Sep 18, 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/1",
  "application_number": "ANDA212931",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bumetanide",
  "start_marketing_date": "20250301",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code C03CA02.

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