NDC 0615-8239

Sevelamer Carbonate

Sevelamer Carbonate

Sevelamer Carbonate is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Inc Dba Vangard Labs. The primary component is Sevelamer Carbonate.

Product ID0615-8239_73bf1774-26ec-4fee-a1db-8d7ae42e2721
NDC0615-8239
Product TypeHuman Prescription Drug
Proprietary NameSevelamer Carbonate
Generic NameSevelamer Carbonate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-07-17
Marketing CategoryANDA / ANDA
Application NumberANDA207179
Labeler NameNCS HealthCare of KY, Inc dba Vangard Labs
Substance NameSEVELAMER CARBONATE
Active Ingredient Strength800 mg/1
Pharm ClassesPhosphate Binder [EPC],Phosphate Chelating Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0615-8239-39

30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8239-39)
Marketing Start Date2018-11-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-8239-39 [00615823939]

Sevelamer Carbonate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA207179
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-06

Drug Details

Active Ingredients

IngredientStrength
SEVELAMER CARBONATE800 mg/1

OpenFDA Data

SPL SET ID:ccfde4dd-b258-4baf-995b-a24bed8c84d7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 749206
  • 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

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