FDA.reportPublic FDA data

PENTOSAN

Manufacturer
Compound One Pharmaceuticals Inc.
Effective date
2014-01-06
Label type
BULK INGREDIENT
Version
2
Source
full-release
Hydrated at
2026-06-01 02:47:51

Label at a glance#

ProductPENTOSAN
Active ingredientPENTOSAN POLYSULFATE SODIUM
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

copy of labelcopy of label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0fbf7978-a66d-d22e-cf47-78546f9f9c42Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58645-003-01PENTOSAN1000 g in 1 DRUMPOWDER10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58645-003PENTOSAN POWDER [COMPOUND ONE PHARMACEUTICALS INC.]21 package rows20140107_de8f6836-7604-4070-ad61-00cff66a4dc4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PENTOSAN POLYSULFATE SODIUMACTIVE INGREDIENT914032762Y2
PENTOSAN POLYSULFATE SODIUMACTIVE MOIETY914032762Y2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58645-00358645-003-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
PENTOSAN POLYSULFATE SODIUM914032762YACTIB

Source Document#

Source XML

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ELMIRONPENTOSAN POLYSULFATE SODIUMJanssen Pharmaceuticals, Inc.f0ba651e-3d8a-11df-8fbe-119855d895932024-09-18Warnings, Adverse reactionsName fallback
generic name: PENTOSAN POLYSULFATE SODIUM

Reported adverse events (FAERS/openFDA)#

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