Back to search
🇺🇸

United States · US · US:63323-877_d673c124-d95f-4751-a11a-a26de8740b3a

NebuPent

In shortageOrange BookSPLATC P01CX01

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeP01CX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6332387715
    1 VIAL, SINGLE-DOSE in 1 CARTON (63323-877-15) / 6 mL in 1 VIAL, SINGLE-DOSE

Annotations

Orange Book
N019887
AN
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Pentamidine Isethionate Injection
Raw payload (JSON)
{
  "route": "RESPIRATORY (INHALATION)",
  "spl_meta": {
    "e2ad9d3c-b6c3-4f70-87e0-722a8ff94ccb": {
      "match": "brand_token",
      "title": "NEBUPENT (PENTAMIDINE ISETHIONATE) INHALANT [FRESENIUS KABI USA, LLC]",
      "spl_version": "4",
      "published_date": "2024-10-21"
    }
  },
  "productid": "63323-877_d673c124-d95f-4751-a11a-a26de8740b3a",
  "productndc": "63323-877",
  "dosage_form": "INHALANT",
  "orange_book": {
    "appl_no": "019887",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AN",
        "strength": "300MG/VIAL",
        "product_no": "001",
        "approval_date": "Jun 15, 1989"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "600MG/VIAL",
        "product_no": "002",
        "approval_date": "Mar 22, 1996"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PENTAMIDINE ISETHIONATE",
  "shortage_reason": "Pentamidine Isethionate Injection",
  "shortage_status": "current",
  "proprietary_name": "NebuPent",
  "active_ingred_unit": "mg/6mL",
  "application_number": "NDA019887",
  "marketing_category": "NDA",
  "nonproprietary_name": "PENTAMIDINE ISETHIONATE",
  "start_marketing_date": "20110215",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code P01CX01.

Access this data programmatically

Query NebuPent and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.