NDC 0955-1048

Sevelamer Hydrochloride

Sevelamer Hydrochloride

Sevelamer Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Winthrop U.s.. The primary component is Sevelamer Hydrochloride.

Product ID0955-1048_65e36e3d-4650-4f33-b233-7e89ef511093
NDC0955-1048
Product TypeHuman Prescription Drug
Proprietary NameSevelamer Hydrochloride
Generic NameSevelamer Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-02-13
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA021179
Labeler NameWinthrop U.S.
Substance NameSEVELAMER HYDROCHLORIDE
Active Ingredient Strength800 mg/1
Pharm ClassesPhosphate Binder [EPC],Phosphate Chelating Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0955-1048-18

180 TABLET, FILM COATED in 1 BOTTLE (0955-1048-18)
Marketing Start Date2019-02-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0955-1048-18 [00955104818]

Sevelamer Hydrochloride TABLET, FILM COATED
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA021179
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-02-13

Drug Details

Active Ingredients

IngredientStrength
SEVELAMER HYDROCHLORIDE800 mg/1

OpenFDA Data

SPL SET ID:5a76bd76-a6cc-46f1-bb58-660566eaec06
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 857224
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Sevelamer Hydrochloride" or generic name "Sevelamer Hydrochloride"

    NDCBrand NameGeneric Name
    0955-1048Sevelamer HydrochlorideSevelamer Hydrochloride
    60687-449Sevelamer HydrochlorideSevelamer Hydrochloride
    68462-446sevelamer hydrochloridesevelamer hydrochloride
    68462-447sevelamer hydrochloridesevelamer hydrochloride
    70748-172Sevelamer hydrochlorideSevelamer hydrochloride
    70748-173Sevelamer hydrochlorideSevelamer hydrochloride
    58468-0021Renagelsevelamer hydrochloride

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.