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United States · US · US:39822-3030_13f0833c-208d-be41-e063-6294a90a627b

Pentamidine Isethionate

In shortageOrange BookSPLATC P01CX01

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

Identification

ManufacturerXGen Pharmaceuticals DJB, Inc.
CountryUS (United States)
ATC codeP01CX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3982230302
    1 VIAL, SINGLE-DOSE in 1 CARTON (39822-3030-2) / 6 mL in 1 VIAL, SINGLE-DOSE (39822-3030-1)

Annotations

Orange Book
A206983
AN
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Pentamidine Isethionate Injection
Raw payload (JSON)
{
  "route": "RESPIRATORY (INHALATION)",
  "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": "39822-3030_13f0833c-208d-be41-e063-6294a90a627b",
  "productndc": "39822-3030",
  "dosage_form": "INHALANT",
  "orange_book": {
    "appl_no": "206983",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AN",
        "strength": "300MG/VIAL",
        "product_no": "001",
        "approval_date": "Jan 20, 2023"
      }
    ],
    "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/6mL",
  "application_number": "ANDA206983",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PENTAMIDINE ISETHIONATE",
  "start_marketing_date": "20230404",
  "active_numerator_strength": "300"
}

Related drugs

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