NDC 0955-1050

Sevelamer Carbonate

Sevelamer Carbonate

Sevelamer Carbonate 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 Carbonate.

Product ID0955-1050_5dab7971-4eb7-49c3-826c-461d87425daa
NDC0955-1050
Product TypeHuman Prescription Drug
Proprietary NameSevelamer Carbonate
Generic NameSevelamer Carbonate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-02-01
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA022127
Labeler NameWinthrop U.S.
Substance NameSEVELAMER CARBONATE
Active Ingredient Strength800 mg/1
Pharm ClassesPhosphate Binder [EPC],Phosphate Chelating Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0955-1050-27

270 TABLET, FILM COATED in 1 BOTTLE (0955-1050-27)
Marketing Start Date2018-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0955-1050-27 [00955105027]

Sevelamer Carbonate TABLET, FILM COATED
Marketing CategoryNDA authorized generic
Application NumberNDA022127
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-02-01

Drug Details

Active Ingredients

IngredientStrength
SEVELAMER CARBONATE800 mg/1

OpenFDA Data

SPL SET ID:3abc32fe-1bfc-4759-8f7c-36095e221b06
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861375
  • 749206
  • 861370
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    67787-407Sevelamer carbonateSevelamer carbonate
    69097-893Sevelamer carbonateSevelamer carbonate
    70518-0909Sevelamer carbonateSevelamer carbonate
    70518-0773Sevelamer CarbonateSevelamer Carbonate
    70518-1102Sevelamer CarbonateSevelamer Carbonate
    70518-1707Sevelamer CarbonateSevelamer Carbonate
    76282-407Sevelamer carbonateSevelamer carbonate
    50436-0893Sevelamer carbonateSevelamer carbonate
    50268-720Sevelamer CarbonateSevelamer Carbonate
    52536-800Sevelamer carbonateSevelamer carbonate
    55111-789Sevelamer CarbonateSevelamer Carbonate
    60429-983Sevelamer CarbonateSevelamer Carbonate
    60687-328Sevelamer CarbonateSevelamer Carbonate
    65162-058Sevelamer CarbonateSevelamer Carbonate
    65862-930SEVELAMER CARBONATESEVELAMER CARBONATE
    65862-931SEVELAMER CARBONATESEVELAMER CARBONATE
    65862-921Sevelamer CarbonateSevelamer Carbonate
    69097-967Sevelamer carbonateSevelamer carbonate
    76282-664Sevelamer carbonateSevelamer carbonate
    70518-2490Sevelamer CarbonateSevelamer Carbonate
    55154-8188Sevelamer CarbonateSevelamer Carbonate
    17856-0130RenvelaSEVELAMER CARBONATE

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