NDC 58468-0131

Renvela

Sevelamer Carbonate

Renvela is a Oral Powder, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Genzyme Corporation. The primary component is Sevelamer Carbonate.

Product ID58468-0131_0bb21936-57aa-481a-a51c-a20090f4d983
NDC58468-0131
Product TypeHuman Prescription Drug
Proprietary NameRenvela
Generic NameSevelamer Carbonate
Dosage FormPowder, For Suspension
Route of AdministrationORAL
Marketing Start Date2009-08-12
Marketing CategoryNDA / NDA
Application NumberNDA022318
Labeler NameGenzyme Corporation
Substance NameSEVELAMER CARBONATE
Active Ingredient Strength2400 mg/1
Pharm ClassesPhosphate Binder [EPC],Phosphate Chelating Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 58468-0131-2

90 PACKET in 1 CARTON (58468-0131-2) > 1 POWDER, FOR SUSPENSION in 1 PACKET (58468-0131-1)
Marketing Start Date2009-08-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58468-0131-4 [58468013104]

Renvela POWDER, FOR SUSPENSION
Marketing CategoryNDA
Application NumberNDA022318
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-08-12

NDC 58468-0131-2 [58468013102]

Renvela POWDER, FOR SUSPENSION
Marketing CategoryNDA
Application NumberNDA022318
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-08-12

NDC 58468-0131-1 [58468013101]

Renvela POWDER, FOR SUSPENSION
Marketing CategoryNDA
Application NumberNDA022318
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-08-12

NDC 58468-0131-3 [58468013103]

Renvela POWDER, FOR SUSPENSION
Marketing CategoryNDA
Application NumberNDA022318
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-08-12

NDC 58468-0131-5 [58468013105]

Renvela POWDER, FOR SUSPENSION
Marketing CategoryNDA
Application NumberNDA022318
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-08-12

Drug Details

Active Ingredients

IngredientStrength
SEVELAMER CARBONATE2400 mg/1

OpenFDA Data

SPL SET ID:e6328460-a57b-450b-a48c-6dcd4b476360
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 749210
  • 749206
  • 861375
  • 861377
  • 861370
  • 861373
  • Pharmacological Class

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

    Medicade Reported Pricing

    58468013102 RENVELA 2.4 GM POWDER PACKET

    Pricing Unit: EA | Drug Type:

    58468013101 RENVELA 2.4 GM POWDER PACKET

    Pricing Unit: EA | Drug Type:

    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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