FDA.reportPublic FDA data

NDC 63323-113-01 - Pentam 300

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
63323-113
Requested NDC
63323-113-01
Package NDCs from labels
63323-113-01, 63323-113-10
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2022-09-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pentam 300 - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2022-09-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-113-01Pentam 3003 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,33
63323-113-10Pentam 30010 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-113PENTAM 300 (PENTAMIDINE ISETHIONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]3Current NDC, Legacy NDC, 2 package rows20220919_cc2b635e-4840-4dc3-a177-5484371680e8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-113-01EA - Each63323-113a8711af0-cae6-4608-b60b-5661909438de12024-04-05
63323-113-10EA - Each63323-1137d710c79-d404-49fb-a1a9-1710eaffa1ff12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PENTAMIDINE ISETHIONATEACTIVE INGREDIENTV2P3K60DA2PENTAM 300 (PENTAMIDINE ISETHIONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC]1
PENTAMIDINEACTIVE MOIETY673LC5J4LQPENTAM 300 (PENTAMIDINE ISETHIONATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC]1

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
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
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
application number: NDA019264
ndc (package): 63323-113-10
ndc (package): 63323-113-01
ndc (product): 63323-113
ndc11 (package): 63323011301
rxcui: 861601
rxcui: 861604
spl id: 5fe83fb0-2b64-40a2-a996-aaa6292e661e
spl set id: cc2b635e-4840-4dc3-a177-5484371680e8
unii: V2P3K60DA2

Reported adverse events (FAERS/openFDA)#

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