FDA.reportPublic FDA data

NDC 39822-3030-1 - Pentamidine Isethionate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
39822-3030
Requested NDC
39822-3030-1
Package NDCs from labels
39822-3030-1, 39822-3030-2
Manufacturer
XGen Pharmaceuticals DJB, Inc.
Effective date
2026-10-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pentamidine Isethionate for Inhalation, 300mg/vialXGen Pharmaceuticals DJB, Inc.2026-10-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39822-3030-1Pentamidine Isethionate6 mL in 1 VIAL, SINGLE-DOSEINHALANT66
39822-3030-2Pentamidine Isethionate1 in 1 CARTONINHALANT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39822-3030PENTAMIDINE ISETHIONATE INHALANT [XGEN PHARMACEUTICALS DJB, INC.]6Current NDC, 2 package rows20240320_490a231d-bb24-403d-9733-1a562ecd5917.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39822-3030-1EA - Each39822-303066f4b4e2-7c76-4e82-851e-b887e19e234612023-07-06
39822-3030-2EA - Each39822-303026e07bd3-dddf-43aa-aae5-f51bc1ff224912023-07-06

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pentamidine IsethionatePENTAMIDINE ISETHIONATEPAI Holdings, LLC dba PAI Pharma4c01d8e9-a25b-4046-8924-53bd9acd560d2026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 861597
unii: V2P3K60DA2
Pentamidine IsethionatePENTAMIDINE ISETHIONATEPAI Holdings, LLC dba PAI Pharmad46aea4f-8f3f-4ce0-93d6-94e147f5a31a2026-05-07Warnings, Adverse reactionsExact identifier
unii: V2P3K60DA2
pentamidine isethionatePENTAMIDINE ISETHIONATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.5c14fbf2-e21f-44b3-b35c-06919d40d7e02025-10-31Warnings, Adverse reactionsExact identifier
unii: V2P3K60DA2
Pentamidine IsethionatePENTAMIDINE ISETHIONATESeton Pharmaceuticalsc484f16e-9d97-4416-84a4-8ad8deaf5e192025-04-08Warnings, Adverse reactionsExact identifier
rxcui: 861597
unii: V2P3K60DA2
Pentamidine IsethionatePENTAMIDINE ISETHIONATESeton Pharmaceuticalscb8e8155-5505-44d5-9dee-525e2e45b95d2025-04-02Warnings, Adverse reactionsExact identifier
unii: V2P3K60DA2
NebuPentPENTAMIDINE ISETHIONATEFresenius Kabi USA, LLCe2ad9d3c-b6c3-4f70-87e0-722a8ff94ccb2024-10-15Warnings, Adverse reactionsExact identifier
rxcui: 861597
unii: V2P3K60DA2
Pentamidine IsethionatePENTAMIDINE ISETHIONATEXGen Pharmaceuticals DJB, Inc.490a231d-bb24-403d-9733-1a562ecd59172024-03-18Warnings, Adverse reactionsExact identifier
application number: ANDA206983
ndc (package): 39822-3030-1
ndc (package): 39822-3030-2
ndc (product): 39822-3030
ndc11 (package): 39822303001
rxcui: 861597
spl id: 13f0833c-208d-be41-e063-6294a90a627b
spl set id: 490a231d-bb24-403d-9733-1a562ecd5917
unii: V2P3K60DA2
PENTAMIDINE ISETHIONATEPENTAMIDINE ISETHIONATEXGen Pharmaceuticals DJB, Inc.860c799c-5199-4f0c-b21b-9910273474d92024-01-25Warnings, Adverse reactionsExact identifier
unii: V2P3K60DA2
Pentam 300PENTAMIDINE ISETHIONATEFresenius Kabi USA, LLCcc2b635e-4840-4dc3-a177-5484371680e82022-09-13Warnings, Adverse reactionsExact identifier
unii: V2P3K60DA2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.