0955-1048 : Sevelamer Hydrochloride 800 mg Oral Tablet, Film Coated


NDC0955-1048
Labeler: Winthrop U.S.
Product Type: Human Prescription Drug
Drug Name:  Sevelamer Hydrochloride
Dosage Form: Oral Tablet, Film Coated
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.

NDC Package Codes:

  • 0955-1048-18: 180 TABLET, FILM COATED IN 1 BOTTLE (0955‑1048‑18)

Active Ingredients:

  • Sevelamer Hydrochloride

Dosage Strength:

  • 800 mg

Inactive Ingredients:

  • Hypromellose, Unspecified
  • Diacetylated Monoglycerides
  • Silicon Dioxide
  • Stearic Acid
  • Ferrosoferric Oxide /

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 33342-241 Sevelamer Hydrochloride 400 mg Oral Tablet, Film Coated by Macleods Pharmaceuticals Limited
  • 33342-242 Sevelamer Hydrochloride 800 mg Oral Tablet, Film Coated by Macleods Pharmaceuticals Limited
  • 59651-087 Sevelamer Hydrochloride 400 mg Oral Tablet, Film Coated by Aurobindo Pharma Limited
  • 59651-088 Sevelamer Hydrochloride 800 mg Oral Tablet, Film Coated by Aurobindo Pharma Limited
  • 60687-449 Sevelamer Hydrochloride 800 mg Oral Tablet, Film Coated by American Health Packaging
  • 68462-446 Sevelamer Hydrochloride 400 mg Oral Tablet, Film Coated by Glenmark Pharmaceuticals Inc., USA
  • 68462-447 Sevelamer Hydrochloride 800 mg Oral Tablet, Film Coated by Glenmark Pharmaceuticals Inc., USA
  • 70748-172 Sevelamer Hydrochloride 400 mg Oral Tablet by Lupin Pharmaceuticals, Inc.
  • 70748-173 Sevelamer Hydrochloride 800 mg Oral Tablet by Lupin Pharmaceuticals, Inc.
  • 72603-148 Sevelamer Hydrochloride 800 mg Oral Tablet, Film Coated by Northstar Rxllc

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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.