FDA.reportPublic FDA data

NDC 0121-1101-55 - 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
0121-1101
Requested NDC
0121-1101-55
Package NDCs from labels
0121-1101-55, 0121-1101-02
Manufacturer
PAI Holdings, LLC dba PAI Pharma
Effective date
2026-05-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pentamidine Isethionate - PAI Holdings, LLC dba PAI PharmaPAI Holdings, LLC dba PAI Pharma2026-05-07HUMAN PRESCRIPTION DRUG LABEL

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 7 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
application number: ANDA206666
ndc (package): 0121-1101-02
ndc (package): 0121-1101-55
ndc (product): 0121-1101
ndc11 (package): 00121110155
rxcui: 861601
spl id: f1a6483e-a7cf-4b6e-9372-458a0a8982f9
spl set id: d46aea4f-8f3f-4ce0-93d6-94e147f5a31a
unii: V2P3K60DA2
pentamidine isethionatePENTAMIDINE ISETHIONATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.5c14fbf2-e21f-44b3-b35c-06919d40d7e02025-10-31Warnings, Adverse reactionsExact identifier
rxcui: 861601
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
application number: ANDA206666
rxcui: 861601
unii: V2P3K60DA2
NebuPentPENTAMIDINE ISETHIONATEFresenius Kabi USA, LLCe2ad9d3c-b6c3-4f70-87e0-722a8ff94ccb2024-10-15Warnings, Adverse reactionsExact identifier
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.