elmiron

Generic: pentosan polysulfate sodium

Labeler: janssen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name elmiron
Generic Name pentosan polysulfate sodium
Labeler janssen pharmaceuticals, inc.
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

pentosan polysulfate sodium 100 mg/1

Manufacturer
Janssen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50458-098
Product ID 50458-098_2268b774-ecba-3038-e063-6394a90a9210
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020193
Listing Expiration 2026-12-31
Marketing Start 1996-09-26

Pharmacologic Class

Classes
glycosaminoglycan [epc] glycosaminoglycans [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50458098
Hyphenated Format 50458-098

Supplemental Identifiers

RxCUI
199498 211140
UPC
0350458098013
UNII
914032762Y

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name elmiron (source: ndc)
Generic Name pentosan polysulfate sodium (source: ndc)
Application Number NDA020193 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE, GELATIN COATED in 1 BOTTLE (50458-098-01)
source: ndc

Packages (1)

50458-098-01 100 CAPSULE, GELATIN COATED in 1 BOTTLE (50458-098-01)

Ingredients (1)

pentosan polysulfate sodium (100 mg/1)

Linked Drug Pages (1)

ELMIRON ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2268b774-ecba-3038-e063-6394a90a9210", "openfda": {"upc": ["0350458098013"], "unii": ["914032762Y"], "rxcui": ["199498", "211140"], "spl_set_id": ["f0ba651e-3d8a-11df-8fbe-119855d89593"], "manufacturer_name": ["Janssen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, GELATIN COATED in 1 BOTTLE (50458-098-01)", "package_ndc": "50458-098-01", "marketing_start_date": "19960926"}], "brand_name": "ELMIRON", "product_id": "50458-098_2268b774-ecba-3038-e063-6394a90a9210", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Glycosaminoglycan [EPC]", "Glycosaminoglycans [CS]"], "product_ndc": "50458-098", "generic_name": "PENTOSAN POLYSULFATE SODIUM", "labeler_name": "Janssen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ELMIRON", "active_ingredients": [{"name": "PENTOSAN POLYSULFATE SODIUM", "strength": "100 mg/1"}], "application_number": "NDA020193", "marketing_category": "NDA", "marketing_start_date": "19960926", "listing_expiration_date": "20261231"}