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United States · US · US:13925-515_c83ced5f-9bf2-4367-9146-5b17d0b83371

Pentamidine Isethionate

In shortageOrange BookSPLATC P01CX01

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

Identification

ManufacturerSeton Pharmaceuticals
CountryUS (United States)
ATC codeP01CX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1392551510
    10 VIAL in 1 TRAY (13925-515-10) / 300 mg in 1 VIAL

Annotations

Orange Book
A206666
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Pentamidine Isethionate Injection
Raw payload (JSON)
{
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "5c14fbf2-e21f-44b3-b35c-06919d40d7e0": {
      "match": "brand_token",
      "title": "PENTAMIDINE ISETHIONATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]",
      "spl_version": "7",
      "published_date": "2025-11-17"
    }
  },
  "productid": "13925-515_c83ced5f-9bf2-4367-9146-5b17d0b83371",
  "productndc": "13925-515",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "206666",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "300MG/VIAL",
        "product_no": "001",
        "approval_date": "Sep 28, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PENTAMIDINE ISETHIONATE",
  "shortage_reason": "Pentamidine Isethionate Injection",
  "shortage_status": "current",
  "proprietary_name": "Pentamidine Isethionate",
  "active_ingred_unit": "mg/300mg",
  "application_number": "ANDA206666",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pentamidine Isethionate",
  "start_marketing_date": "20180401",
  "active_numerator_strength": "300"
}

Related drugs

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