NDC 68462-446

sevelamer hydrochloride

Sevelamer Hydrochloride

sevelamer hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Glenmark Pharmaceuticals Inc., Usa. The primary component is Sevelamer Hydrochloride.

Product ID68462-446_2cd6512f-0edd-4a30-a4fa-aa996038633c
NDC68462-446
Product TypeHuman Prescription Drug
Proprietary Namesevelamer hydrochloride
Generic NameSevelamer Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-02-08
Marketing CategoryANDA / ANDA
Application NumberANDA204724
Labeler NameGlenmark Pharmaceuticals Inc., USA
Substance NameSEVELAMER HYDROCHLORIDE
Active Ingredient Strength400 mg/1
Pharm ClassesPhosphate Binder [EPC],Phosphate Chelating Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68462-446-26

360 TABLET, FILM COATED in 1 BOTTLE (68462-446-26)
Marketing Start Date2019-02-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68462-446-30 [68462044630]

sevelamer hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204724
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-08

NDC 68462-446-26 [68462044626]

sevelamer hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA204724
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-02-08

Drug Details

Active Ingredients

IngredientStrength
SEVELAMER HYDROCHLORIDE400 mg/1

OpenFDA Data

SPL SET ID:2cd6512f-0edd-4a30-a4fa-aa996038633c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 857216
  • 857224
  • UPC Code
  • 0368462446263
  • 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

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