🇺🇸
United States · US · US:63323-877_d673c124-d95f-4751-a11a-a26de8740b3a
NebuPent
In shortageOrange BookSPLATC 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
- ndc1163323877151 VIAL, SINGLE-DOSE in 1 CARTON (63323-877-15) / 6 mL in 1 VIAL, SINGLE-DOSE
Annotations
Orange Book
N019887
AN
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Pentamidine Isethionate Injection
Raw payload (JSON)
{
"route": "RESPIRATORY (INHALATION)",
"spl_meta": {
"e2ad9d3c-b6c3-4f70-87e0-722a8ff94ccb": {
"match": "brand_token",
"title": "NEBUPENT (PENTAMIDINE ISETHIONATE) INHALANT [FRESENIUS KABI USA, LLC]",
"spl_version": "4",
"published_date": "2024-10-21"
}
},
"productid": "63323-877_d673c124-d95f-4751-a11a-a26de8740b3a",
"productndc": "63323-877",
"dosage_form": "INHALANT",
"orange_book": {
"appl_no": "019887",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AN",
"strength": "300MG/VIAL",
"product_no": "001",
"approval_date": "Jun 15, 1989"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "600MG/VIAL",
"product_no": "002",
"approval_date": "Mar 22, 1996"
}
],
"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": "NebuPent",
"active_ingred_unit": "mg/6mL",
"application_number": "NDA019887",
"marketing_category": "NDA",
"nonproprietary_name": "PENTAMIDINE ISETHIONATE",
"start_marketing_date": "20110215",
"active_numerator_strength": "300"
}Related drugs
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