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United States · US · US:83634-302_1b3f2803-b618-4447-b5ac-cd2bdc7de3e8

Furosemide

In shortageOrange BookUNIISPLATC C03CA01

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

Identification

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

Packs · 3

  • ndc11
    8363430202
    25 VIAL, SINGLE-DOSE in 1 CARTON (83634-302-02) / 2 mL in 1 VIAL, SINGLE-DOSE (83634-302-42)
  • ndc11
    8363430204
    25 VIAL, SINGLE-DOSE in 1 CARTON (83634-302-04) / 4 mL in 1 VIAL, SINGLE-DOSE (83634-302-43)
  • ndc11
    8363430210
    25 VIAL, SINGLE-DOSE in 1 CARTON (83634-302-10) / 10 mL in 1 VIAL, SINGLE-DOSE (83634-302-41)

Annotations

UNII (FDA Substance ID)
7LXU5N7ZO5
FUROSEMIDE
RxCUI 4603
Orange Book
A203428
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Furosemide Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "7LXU5N7ZO5",
    "rxcui": "4603",
    "inchikey": "ZZUFCTLCJUWOSV-UHFFFAOYSA-N",
    "display_name": "FUROSEMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "6d9caaab-d874-4cf1-b9fe-408452a18998": {
      "match": "brand_token",
      "title": "FUROSEMIDE INJECTION [CIVICA, INC.]",
      "spl_version": "1",
      "published_date": "2026-05-28"
    }
  },
  "productid": "83634-302_1b3f2803-b618-4447-b5ac-cd2bdc7de3e8",
  "productndc": "83634-302",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "203428",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "10MG/ML",
        "product_no": "001",
        "approval_date": "Aug 26, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FUROSEMIDE",
  "shortage_reason": "Furosemide Injection",
  "shortage_status": "current",
  "proprietary_name": "Furosemide",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA203428",
  "marketing_category": "ANDA",
  "nonproprietary_name": "furosemide",
  "start_marketing_date": "20240315",
  "active_numerator_strength": "10"
}

Related drugs

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