Sevelamer Carbonate

Product NDC
55154-3358
11-digit product format
551543358
Labeler code
55154
Product ID
55154-3358_d32d8ace-7628-4b19-805b-83541f82ce35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevelamer Carbonate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA206094
Marketing category
ANDA
Marketing start
2017-09-29
Marketing end
2026-12-31
Substance
SEVELAMER CARBONATE
Active strength
800 mg/1
Pharmacologic classes
Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sevelamer Carbonate

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-3358-0Sevelamer Carbonate10 in 1 BAGTABLET, FILM COATED106
55154-3358-0Sevelamer Carbonate1 in 1 BLISTER PACKTABLET, FILM COATED16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-3358SEVELAMER CARBONATE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]4Current NDC, Legacy NDC, 2 package rows20240910_65184825-adce-480e-a4c3-b21e37656cf4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749206sevelamer carbonate 800 MG Oral TabletPSN65184825-adce-480e-a4c3-b21e37656cf46
749206sevelamer carbonate 800 MG Oral TabletSCD65184825-adce-480e-a4c3-b21e37656cf46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-3358-05515433580010 BLISTER PACK in 1 BAG (55154-3358-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2017-09-292026-12-31NoNoCurrent