52125-435 : Sevelamer Hydrochloride 800 mg Oral Tablet


NDC: 52125-435
Labeler: Remedyrepack Inc.
Product Type: Human Prescription Drug
Drug Name:  Renagel
Dosage Form: Oral Tablet
Application #: NDA021179
Rev. Date: 


Appearance:


Markings: RENAGEL;800
Shapes:  Oval
Colors:  White
Size (mm): 19
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.

RENAGEL 800: (58468-0021) Sevelamer Hydrochloride 800 mg Oral Tablet by Remedyrepack 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:

  • 52125-435-02: 30 TABLET IN 1 BLISTER PACK (52125‑435‑02)

Active Ingredients:

  • Sevelamer Hydrochloride

Dosage Strength:

  • 800 mg

Inactive Ingredients:

  • Colloidal Silicon Dioxide
  • Ferrosoferric Oxide
  • Hypromellose 2910 (15 Mpa.s)
  • Propylene Glycol
  • Hypromellose 2910 (5 Mpa.s)
  • Stearic Acid
  • Isopropyl Alcohol
  • Water

Pharmaceutical Classes:

  • Phosphate Binder [EPC]
  • Phosphate Chelating Activity [MoA]

Related Products:

Based on records with the same trade name.
  • 17856-0021 Renagel 800 mg Oral Tablet by Atlantic Biologicals Corps
  • 53808-0777 Sevelamer Hydrochloride 800 mg Oral Tablet by State of Florida Doh Central Pharmacy
  • 55154-9726 Renagel 400 mg Oral Tablet by Cardinal Health
  • 55154-9727 Renagel 800 mg Oral Tablet by Cardinal Health
  • 58468-0020 Sevelamer Hydrochloride 400 mg Oral Tablet by Genzyme Corporation
  • 58468-0021 Sevelamer Hydrochloride 800 mg Oral Tablet by Genzyme Corporation
  • 67544-656 Renagel 800 mg Oral Tablet by Aphena Pharma Solutions - Tennessee, LLC
  • 68151-4295 Renagel 400 mg Oral Tablet by Carilion Materials Management

NDC 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.