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United States · US · US:84388-005_f23216fe-f3a4-4550-8b47-eaaef86d9356

Enbumyst

In shortageOrange BookUNIISPLATC C03CA02

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

Identification

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

Packs · 2

  • ndc11
    8438800506
    6 BLISTER PACK in 1 CARTON (84388-005-06) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    8438800512
    12 BLISTER PACK in 1 CARTON (84388-005-12) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
0Y2S3XUQ5H
BUMETANIDE
RxCUI 1808
Orange Book
N219500
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": "NASAL",
  "spl_meta": {
    "d6f752c5-d2bd-4f77-9611-ca2110066d1f": {
      "match": "brand_token",
      "title": "ENBUMYST (BUMETANIDE) SPRAY [CORSTASIS USA LLC]",
      "spl_version": "3",
      "published_date": "2026-01-06"
    }
  },
  "productid": "84388-005_f23216fe-f3a4-4550-8b47-eaaef86d9356",
  "productndc": "84388-005",
  "dosage_form": "SPRAY",
  "orange_book": {
    "appl_no": "219500",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.5MG/SPRAY",
        "product_no": "001",
        "approval_date": "Sep 12, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUMETANIDE",
  "shortage_reason": "Bumetanide Injection",
  "shortage_status": "current",
  "proprietary_name": "Enbumyst",
  "active_ingred_unit": "mg/.1mL",
  "application_number": "NDA219500",
  "marketing_category": "NDA",
  "nonproprietary_name": "bumetanide",
  "start_marketing_date": "20250912",
  "active_numerator_strength": ".5"
}

Related drugs

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