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United States · US · US:63323-113_5fe83fb0-2b64-40a2-a996-aaa6292e661e

Pentam 300

In shortageOrange BookATC 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
    6332311310
    10 VIAL in 1 TRAY (63323-113-10) / 3 mL in 1 VIAL (63323-113-01)

Annotations

Orange Book
N019264
AP
FDA shortage
Currently in shortage
Pentamidine Isethionate Injection
Raw payload (JSON)
{
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "productid": "63323-113_5fe83fb0-2b64-40a2-a996-aaa6292e661e",
  "productndc": "63323-113",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "019264",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "300MG/VIAL",
        "product_no": "001",
        "approval_date": "Oct 16, 1984"
      }
    ],
    "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": "Pentam 300",
  "active_ingred_unit": "mg/3mL",
  "application_number": "NDA019264",
  "marketing_category": "NDA",
  "nonproprietary_name": "PENTAMIDINE ISETHIONATE",
  "start_marketing_date": "20010116",
  "active_numerator_strength": "300"
}

Related drugs

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