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United States · US · US:30698-630_3e4799b2-7621-c0b4-e063-6394a90a47b7

Bumex

In shortageOrange BookUNIISPLATC C03CA02

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

Identification

ManufacturerValidus Pharmaceuticals LLC
CountryUS (United States)
ATC codeC03CA02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3069863001
    100 TABLET in 1 BOTTLE (30698-630-01)

Annotations

UNII (FDA Substance ID)
0Y2S3XUQ5H
BUMETANIDE
RxCUI 1808
Orange Book
N018225
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": {
    "32dfbea3-eb2b-4070-8605-57ce3e6d5a2f": {
      "match": "brand_token",
      "title": "BUMEX (BUMETANIDE) TABLET [VALIDUS PHARMACEUTICALS LLC]",
      "spl_version": "5",
      "published_date": "2025-09-10"
    }
  },
  "productid": "30698-630_3e4799b2-7621-c0b4-e063-6394a90a47b7",
  "productndc": "30698-630",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "018225",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Feb 28, 1983"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Feb 28, 1983"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "003",
        "approval_date": "Jun 14, 1985"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUMETANIDE",
  "shortage_reason": "Bumetanide Injection",
  "shortage_status": "current",
  "proprietary_name": "Bumex",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA018225",
  "marketing_category": "NDA",
  "nonproprietary_name": "Bumetanide",
  "start_marketing_date": "19830228",
  "active_numerator_strength": ".5"
}

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