FDA.reportPublic FDA data

Sevelamer Carbonate

Product NDC
17856-0921
11-digit product format
178560921
Labeler code
17856
Product ID
17856-0921_38930d7d-8bbb-c1f4-e063-6394a90a636e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevelamer Carbonate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA207179
Marketing category
ANDA
Marketing start
2018-06-27
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
86e7ef73-ca63-701e-e952-6c80aa5122b8Product name920210309
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0921-12024-05-09C16284748780-19d75b9d0-aaf2-f424-e053-dadaa90a57ceSEVELAMER CARBONATE TABLETS These 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
17856-0921-12024-01-30C16284748780-19d75b9d0-aaf2-f424-e053-dadaa90a57ceSEVELAMER CARBONATE TABLETS These 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
17856-0921-12021-05-06C16284748780-19d75b9d0-aaf2-f424-e053-dadaa90a57ceSEVELAMER CARBONATE TABLETS These 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
17856-0921-12020-01-31C16284748780-19d75b9d0-aaf2-f424-e053-dadaa90a57ceSEVELAMER CARBONATE TABLETS These 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
17856-0921-1Sevelamer Carbonate100 in 1 CASETABLET, FILM COATED1005
17856-0921-2Sevelamer Carbonate1 in 1 POUCHTABLET, FILM COATED15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0921SEVELAMER CARBONATE TABLET, FILM COATED [ATLANTIC BIOLOGICALS CORP.]4Current NDC, Legacy NDC, 2 package rows20240511_07b709fd-a2a1-4ff1-ad19-827d38e84562.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749206sevelamer carbonate 800 MG Oral TabletPSN07b709fd-a2a1-4ff1-ad19-827d38e845625
749206sevelamer carbonate 800 MG Oral TabletSCD07b709fd-a2a1-4ff1-ad19-827d38e845625

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0921-117856092101100 POUCH in 1 CASE (17856-0921-1) / 1 TABLET, FILM COATED in 1 POUCH (17856-0921-2) 100 pouch2024-05-090000-00-00NoNoCurrent
17856-0921-2178560921021 in 1 POUCHHistorical