🇺🇸
United States · US · US:23155-748_77269af7-78f2-4f7d-bfe9-bdcd2bedaa86
pentamidine isethionate
In shortageOrange BookSPLATC P01CX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
CountryUS (United States)
ATC codeP01CX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11231557484110 VIAL, SINGLE-DOSE in 1 CARTON (23155-748-41) / 300 mg in 1 VIAL, SINGLE-DOSE (23155-748-31)
Annotations
Orange Book
A213806
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": "23155-748_77269af7-78f2-4f7d-bfe9-bdcd2bedaa86",
"productndc": "23155-748",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "213806",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "300MG/VIAL",
"product_no": "001",
"approval_date": "Jan 7, 2021"
}
],
"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": "ANDA213806",
"marketing_category": "ANDA",
"nonproprietary_name": "pentamidine isethionate",
"start_marketing_date": "20210108",
"active_numerator_strength": "300"
}Related drugs
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