🇺🇸
United States · US · US:39822-3050_0fcb7bdf-013e-a77c-e063-6394a90ad20f
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
- ndc11398223050210 VIAL in 1 CARTON (39822-3050-2) / 3 mL in 1 VIAL
Annotations
Orange Book
A206982
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": "39822-3050_0fcb7bdf-013e-a77c-e063-6394a90ad20f",
"productndc": "39822-3050",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "206982",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "300MG/VIAL",
"product_no": "001",
"approval_date": "Mar 17, 2022"
}
],
"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/3mL",
"application_number": "ANDA206982",
"marketing_category": "ANDA",
"nonproprietary_name": "PENTAMIDINE ISETHIONATE",
"start_marketing_date": "20230404",
"active_numerator_strength": "300"
}Related drugs
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