NDC 50458-098

ELMIRON

Pentosan Polysulfate Sodium

ELMIRON is a Oral Capsule, Gelatin Coated in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Pentosan Polysulfate Sodium.

• Product ID: 50458-098_af1cbf19-9fdd-48dd-92dc-2fe1232e43a7
• NDC: 50458-098
• Product Type: Human Prescription Drug
• Proprietary Name: ELMIRON
• Generic Name: Pentosan Polysulfate Sodium
• Dosage Form: Capsule, Gelatin Coated
• Route of Administration: ORAL
• Marketing Start Date: 1996-09-26
• Marketing Category: NDA / NDA
• Application Number: NDA020193
• Labeler Name: Janssen Pharmaceuticals, Inc.
• Substance Name: PENTOSAN POLYSULFATE SODIUM
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Glycosaminoglycan [EPC],Glycosaminoglycans [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 50458-098-01

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

• Marketing Start Date: 1996-09-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50458-098-01 [50458009801]

ELMIRON CAPSULE, GELATIN COATED

• Marketing Category: NDA
• Application Number: NDA020193
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1996-09-26

Drug Details

Active Ingredients

Ingredient	Strength
PENTOSAN POLYSULFATE SODIUM	100 mg/1

OpenFDA Data

• SPL SET ID: f0ba651e-3d8a-11df-8fbe-119855d89593
• Manufacturer:
  • Janssen Pharmaceuticals, Inc.
• UNII:
  • 914032762Y
• RxNorm Concept Unique ID - RxCUI:
  • 199498
  • 211140

Pharmacological Class

• Glycosaminoglycan [EPC]
• Glycosaminoglycans [CS]
• Glycosaminoglycan [EPC]
• Glycosaminoglycans [CS]

Medicade Reported Pricing

50458009801 ELMIRON 100 MG CAPSULE

Pricing Unit: EA | Drug Type: