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United States · US · US:10135-834_4bd1ae61-8ab9-342a-e063-6394a90af1d2

Furosemide

In shortageOrange BookUNIISPLATC C03CA01

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

Identification

ManufacturerMarlex Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC03CA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    1013583401
    100 TABLET in 1 BOTTLE (10135-834-01)
  • ndc11
    1013583405
    500 TABLET in 1 BOTTLE (10135-834-05)
  • ndc11
    1013583490
    90 TABLET in 1 BOTTLE (10135-834-90)

Annotations

UNII (FDA Substance ID)
7LXU5N7ZO5
FUROSEMIDE
RxCUI 4603
Orange Book
N018569
ABABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Furosemide Oral Solution
Raw payload (JSON)
{
  "unii": {
    "unii": "7LXU5N7ZO5",
    "rxcui": "4603",
    "inchikey": "ZZUFCTLCJUWOSV-UHFFFAOYSA-N",
    "display_name": "FUROSEMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "6d9caaab-d874-4cf1-b9fe-408452a18998": {
      "match": "brand_token",
      "title": "FUROSEMIDE INJECTION [CIVICA, INC.]",
      "spl_version": "1",
      "published_date": "2026-05-28"
    }
  },
  "productid": "10135-834_4bd1ae61-8ab9-342a-e063-6394a90af1d2",
  "productndc": "10135-834",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "018569",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "005",
        "approval_date": "Aug 14, 1984"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FUROSEMIDE",
  "shortage_reason": "Furosemide Oral Solution",
  "shortage_status": "current",
  "proprietary_name": "Furosemide",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA018569",
  "marketing_category": "NDA",
  "nonproprietary_name": "FUROSEMIDE",
  "start_marketing_date": "20260301",
  "active_numerator_strength": "80"
}

Related drugs

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