NDC 17856-0130

Renvela

Sevelamer Carbonate

Renvela is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Atlantic Biologicals Corps. The primary component is Sevelamer Carbonate.

Product ID17856-0130_73ae51f5-e9bf-4bb3-af90-3434932f46ef
NDC17856-0130
Product TypeHuman Prescription Drug
Proprietary NameRenvela
Generic NameSevelamer Carbonate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2009-08-12
Marketing CategoryNDA / NDA
Application NumberNDA022127
Labeler NameAtlantic Biologicals Corps
Substance NameSEVELAMER CARBONATE
Active Ingredient Strength800 mg/1
Pharm ClassesPhosphate Binder [EPC],Phosphate Chelating Activity [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 17856-0130-2

100 POUCH in 1 CASE (17856-0130-2) > 1 TABLET, FILM COATED in 1 POUCH
Marketing Start Date2015-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17856-0130-2 [17856013002]

Renvela TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022127
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-01-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
SEVELAMER CARBONATE800 mg/1

OpenFDA Data

SPL SET ID:0edd2144-50b5-40d7-a81f-5f7647adc32a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 749210
  • 749206

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Renvela" or generic name "Sevelamer Carbonate"

    NDCBrand NameGeneric Name
    17856-0130RenvelaSEVELAMER CARBONATE
    68151-5113RenvelaRenvela
    58468-0132RenvelaRenvela
    58468-0131RenvelaRenvela
    58468-0130RenvelaRenvela
    0115-1309Sevelamer CarbonateSevelamer Carbonate
    0115-1365sevelamer carbonatesevelamer carbonate
    0115-1366sevelamer carbonatesevelamer carbonate
    0615-8239Sevelamer CarbonateSevelamer Carbonate
    0904-6707Sevelamer CarbonateSevelamer Carbonate
    0955-1050Sevelamer CarbonateSevelamer Carbonate
    0955-1052Sevelamer CarbonateSevelamer Carbonate
    0955-1054Sevelamer CarbonateSevelamer Carbonate
    10135-660Sevelamer CarbonateSevelamer Carbonate
    16571-739Sevelamer carbonateSevelamer carbonate
    16714-814Sevelamer CarbonateSevelamer Carbonate
    17856-0058Sevelamer CarbonateSevelamer Carbonate
    17856-0921Sevelamer CarbonateSevelamer Carbonate
    24979-186Sevelamer CarbonateSevelamer Carbonate
    42291-763Sevelamer CarbonateSevelamer Carbonate
    42571-378SEVELAMER CARBONATESEVELAMER CARBONATE

    Trademark Results [Renvela]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    RENVELA
    RENVELA
    78674340 3326463 Live/Registered
    GENZYME CORPORATION
    2005-07-20
    RENVELA
    RENVELA
    77228109 3517569 Dead/Cancelled
    Genzyme Corporation
    2007-07-12
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