NDC 70518-0773

Sevelamer Carbonate

Sevelamer Carbonate

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

Product ID70518-0773_5b25f8d5-01cd-93f1-e053-2a91aa0af70a
NDC70518-0773
Product TypeHuman Prescription Drug
Proprietary NameSevelamer Carbonate
Generic NameSevelamer Carbonate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-10-09
Marketing CategoryANDA / ANDA
Application NumberANDA207179
Labeler NameREMEDYREPACK INC.
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 70518-0773-0

30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0773-0)
Marketing Start Date2017-10-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0773-0 [70518077300]

Sevelamer Carbonate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA207179
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-10-09
Marketing End Date2020-05-04

Drug Details

Active Ingredients

IngredientStrength
SEVELAMER CARBONATE800 mg/1

OpenFDA Data

SPL SET ID:534b58e1-67f0-4d21-8a8b-6d9402db5ec6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 749206
  • Pharmacological Class

    • 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.