54868-4525 : Elmiron 100 mg Oral Capsule


NDC: 54868-4525
Labeler: Physicians Total Care, Inc.
Product Type: Human Prescription Drug
Drug Name:  Elmiron
Dosage Form: Oral Capsule, Gelatin Coated
Application #: NDA020193
Rev. Date: 


Appearance:


Markings: BNP7600
Shapes:  Capsule
Colors:  White
Size (mm): 18
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

BNP7600: (50458-098) Elmiron 100 mg Oral Capsule by Physicians Total Care, Inc.
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 54868-4525-0: 100 CAPSULE, GELATIN COATED IN 1 BOTTLE (54868‑4525‑0)
  • 54868-4525-1: 30 CAPSULE, GELATIN COATED IN 1 BOTTLE, PLASTIC (54868‑4525‑1)
  • 54868-4525-2: 10 CAPSULE, GELATIN COATED IN 1 BOTTLE, PLASTIC (54868‑4525‑2)
  • 54868-4525-3: 90 CAPSULE, GELATIN COATED IN 1 BOTTLE, PLASTIC (54868‑4525‑3)

Active Ingredients:

  • Pentosan Polysulfate Sodium

Dosage Strength:

  • 100 mg

Inactive Ingredients:

  • Cellulose, Microcrystalline
  • Magnesium Stearate
  • Ferrosoferric Oxide
  • Fd&c Blue No. 2
  • Fd&c Red No. 40
  • Fd&c Blue No. 1
  • D&c Yellow No. 10
  • Aluminum Oxide
  • Butyl Alcohol
  • Propylene Glycol
  • Titanium Dioxide

Pharmaceutical Classes:

  • Glycosaminoglycan [EPC]
  • Glycosaminoglycans [Chemical/Ingredient]

Related Products:

Based on records with the same trade name.
  • 50458-098 Elmiron 100 mg Oral Capsule by Janssen Pharmaceuticals, Inc.
  • 55154-0553 Elmiron 100 mg/1 Oral Capsule, Gelatin Coated by Cardinal Health

NDC QR Code

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NDC 54868-4525 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.