FDA.reportPublic FDA data

PENTOSAN POLYSULFATE SODIUM

Manufacturer
Kalchem International inc
Effective date
2021-10-22
Label type
BULK INGREDIENT
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:31:01

Label at a glance#

ProductPENTOSAN POLYSULFATE SODIUM
Active ingredientPENTOSAN POLYSULFATE SODIUM
Label structure1 sections

Label contents#

Full prescribing information#

PENTOSAN POLYSULFATE SODIUM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PENTOSANPENTOSAN

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
60592-24060592-240-10

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.