🇺🇸
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
- ndc11633231131010 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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