FDA.reportPublic FDA data

Sevelamer carbonate

Product NDC
76282-664
11-digit product format
762820664
Labeler code
76282
Product ID
76282-664_831095de-d22d-496d-834c-c4505e639c87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SEVELAMER CARBONATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Exelan Pharmaceuticals Inc.
Application
ANDA203860
Marketing category
ANDA
Marketing start
2017-10-26
Substance
SEVELAMER CARBONATE
Active strength
800 mg/1
Pharmacologic classes
Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sevelamer carbonate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SEVELAMER CARBONATE800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9YCX42I8IU
Rxcui749206

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
76282-664-272023-03-23C16284748780-1f386c649-9b2b-0266-e053-dadaa90a7c1aThese 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, for oral use Initial U.S. Approval: 2000
76282-664-272023-01-30C16284748780-1f386c649-9b2b-0266-e053-dadaa90a7c1aThese 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, for oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-664-27Sevelamer carbonate270 in 1 BOTTLETABLET, FILM COATED2703

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-664SEVELAMER CARBONATE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 1 package rows20230324_f8947f65-57be-4af7-b0e7-17666f496d01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749206sevelamer carbonate 800 MG Oral TabletPSNf8947f65-57be-4af7-b0e7-17666f496d013
749206sevelamer carbonate 800 MG Oral TabletSCDf8947f65-57be-4af7-b0e7-17666f496d013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76282-664-2776282066427270 TABLET, FILM COATED in 1 BOTTLE (76282-664-27) 2019-08-080000-00-00NoNoCurrent