🇺🇸
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
- ndc11139255151010 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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