FDA.reportPublic FDA data

Sevelamer carbonate

Product NDC
67787-407
11-digit product format
677870407
Labeler code
67787
Product ID
67787-407_2a1c69d0-6ef6-4c0e-b32b-fd8f2dae5983
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SEVELAMER CARBONATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
InvaGen Pharmaceuticals Inc.
Application
ANDA203860
Marketing category
ANDA
Marketing start
2017-10-26
Marketing end
0000-00-00
Substance
SEVELAMER CARBONATE
Active strength
800 mg/1
Pharmacologic classes
Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5085f16b-f856-182d-a646-425b62d3f565Product name620251118
86e7ef73-ca63-701e-e952-6c80aa5122b8Product name920210309

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67787-407-272024-01-30C16284748780-11030e365-5077-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use SEVELAMER CARBONATE TABLETS safely and effectively. See full prescribing information for SEVELAMER CARBONATE TABLETS. SEVELAMER CARBONATE tablets, film coated for oral use Initial U.S. Approval: 2000
67787-407-302024-01-30C16284748780-11030e365-5077-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use SEVELAMER CARBONATE TABLETS safely and effectively. See full prescribing information for SEVELAMER CARBONATE TABLETS. SEVELAMER CARBONATE tablets, film coated for oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67787-407-27Sevelamer carbonate270 in 1 BOTTLETABLET, FILM COATED2701
67787-407-30Sevelamer carbonate30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67787-407SEVELAMER CARBONATE TABLET, FILM COATED [INVAGEN PHARMACEUTICALS INC.]1Legacy NDC, 2 package rows20171027_40bc25f8-c4f3-4e3a-b120-05adb40e5483.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749206sevelamer carbonate 800 MG Oral TabletPSN40bc25f8-c4f3-4e3a-b120-05adb40e54831
749206sevelamer carbonate 800 MG Oral TabletSCD40bc25f8-c4f3-4e3a-b120-05adb40e54831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67787-407-2767787040727270 TABLET, FILM COATED in 1 BOTTLE (67787-407-27) 2017-10-260000-00-00NoNoCurrent
67787-407-306778704073030 TABLET, FILM COATED in 1 BOTTLE (67787-407-30) 2017-10-260000-00-00NoNoCurrent