FDA.reportPublic FDA data

NDC 23155-748-31 - 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
23155-748
Requested NDC
23155-748-31
Package NDCs from labels
23155-748-31, 23155-748-41
Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | AVET LIFESCIENCES PRIVATE LIMITED | Immacule Lifesciences Private Limited
Effective date
2025-10-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
For Injection OnlyHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | AVET LIFESCIENCES PRIVATE LIMITED | Immacule Lifesciences Private Limited2025-10-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-748-31pentamidine isethionate300 mg in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,3007
23155-748-41pentamidine isethionate10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-748PENTAMIDINE ISETHIONATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 2 package rows20231102_5c14fbf2-e21f-44b3-b35c-06919d40d7e0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-748-31EA - Each23155-74831c31ab1-9b40-4531-b09d-28f2c72cb78412021-06-02
23155-748-41EA - Each23155-74817bed1e9-8809-4cb4-b705-c8205d04996512021-06-02

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
unii: V2P3K60DA2
Pentamidine IsethionatePENTAMIDINE ISETHIONATEPAI Holdings, LLC dba PAI Pharmad46aea4f-8f3f-4ce0-93d6-94e147f5a31a2026-05-07Warnings, Adverse reactionsExact identifier
rxcui: 861601
unii: V2P3K60DA2
pentamidine isethionatePENTAMIDINE ISETHIONATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.5c14fbf2-e21f-44b3-b35c-06919d40d7e02025-10-31Warnings, Adverse reactionsExact identifier
application number: ANDA213806
ndc (package): 23155-748-31
ndc (package): 23155-748-41
ndc (product): 23155-748
ndc11 (package): 23155074831
rxcui: 861601
spl id: 77269af7-78f2-4f7d-bfe9-bdcd2bedaa86
spl set id: 5c14fbf2-e21f-44b3-b35c-06919d40d7e0
unii: V2P3K60DA2
Pentamidine IsethionatePENTAMIDINE ISETHIONATESeton Pharmaceuticalsc484f16e-9d97-4416-84a4-8ad8deaf5e192025-04-08Warnings, Adverse reactionsExact identifier
unii: V2P3K60DA2
Pentamidine IsethionatePENTAMIDINE ISETHIONATESeton Pharmaceuticalscb8e8155-5505-44d5-9dee-525e2e45b95d2025-04-02Warnings, Adverse reactionsExact identifier
rxcui: 861601
unii: V2P3K60DA2
NebuPentPENTAMIDINE ISETHIONATEFresenius Kabi USA, LLCe2ad9d3c-b6c3-4f70-87e0-722a8ff94ccb2024-10-15Warnings, Adverse reactionsExact identifier
unii: V2P3K60DA2
Pentamidine IsethionatePENTAMIDINE ISETHIONATEXGen Pharmaceuticals DJB, Inc.490a231d-bb24-403d-9733-1a562ecd59172024-03-18Warnings, Adverse reactionsExact identifier
unii: V2P3K60DA2
PENTAMIDINE ISETHIONATEPENTAMIDINE ISETHIONATEXGen Pharmaceuticals DJB, Inc.860c799c-5199-4f0c-b21b-9910273474d92024-01-25Warnings, Adverse reactionsExact identifier
rxcui: 861601
unii: V2P3K60DA2
Pentam 300PENTAMIDINE ISETHIONATEFresenius Kabi USA, LLCcc2b635e-4840-4dc3-a177-5484371680e82022-09-13Warnings, Adverse reactionsExact identifier
rxcui: 861601
unii: V2P3K60DA2

Reported adverse events (FAERS/openFDA)#

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