ELMIRON

Orange BookUNIISPLATC C05BA04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerJanssen Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeC05BA04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5045809801
100 CAPSULE, GELATIN COATED in 1 BOTTLE (50458-098-01)

Annotations

UNII (FDA Substance ID)

914032762Y

PENTOSAN POLYSULFATE SODIUM

RxCUI 134413

Orange Book

N020193

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "914032762Y",
    "rxcui": "134413",
    "inchikey": null,
    "display_name": "PENTOSAN POLYSULFATE SODIUM",
    "substance_type": "polymer",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f0ba651e-3d8a-11df-8fbe-119855d89593": {
      "match": "brand_token",
      "title": "ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPSULE, GELATIN COATED [JANSSEN PHARMACEUTICALS, INC.]",
      "spl_version": "16",
      "published_date": "2024-09-20"
    }
  },
  "productid": "50458-098_2268b774-ecba-3038-e063-6394a90a9210",
  "productndc": "50458-098",
  "dosage_form": "CAPSULE, GELATIN COATED",
  "orange_book": {
    "appl_no": "020193",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Sep 26, 1996"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PENTOSAN POLYSULFATE SODIUM",
  "proprietary_name": "ELMIRON",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020193",
  "marketing_category": "NDA",
  "nonproprietary_name": "PENTOSAN POLYSULFATE SODIUM",
  "start_marketing_date": "19960926",
  "active_numerator_strength": "100"
}

Related drugs

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