Sevelamer Carbonate

Product NDC
0955-1050
11-digit product format
009551050
Labeler code
0955
Product ID
0955-1050_42bdb389-5550-487c-aed2-c4e3afd239c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevelamer Carbonate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sanofi-Aventis U.S. LLC
Application
NDA022127
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-02-01
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, 861370, 861375

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
0955-1050-27Sevelamer Carbonate270 in 1 BOTTLETABLET, FILM COATED27020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0955-1050-27EA - Each0955-10504ab1951a-d2bb-414b-852d-c8133fb7ce5b12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0955-1050SEVELAMER CARBONATE TABLET, FILM COATED SEVELAMER CARBONATE POWDER, FOR SUSPENSION [SANOFI-AVENTIS U.S. LLC]19Current NDC, Legacy NDC, 1 package rows20250213_3abc32fe-1bfc-4759-8f7c-36095e221b06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861375sevelamer carbonate 0.8 GM Powder for Oral SuspensionPSN3abc32fe-1bfc-4759-8f7c-36095e221b0620
861370sevelamer carbonate 2.4 GM Powder for Oral SuspensionPSN3abc32fe-1bfc-4759-8f7c-36095e221b0620
749206sevelamer carbonate 800 MG Oral TabletPSN3abc32fe-1bfc-4759-8f7c-36095e221b0620
861370sevelamer carbonate 2400 MG Powder for Oral SuspensionSCD3abc32fe-1bfc-4759-8f7c-36095e221b0620
749206sevelamer carbonate 800 MG Oral TabletSCD3abc32fe-1bfc-4759-8f7c-36095e221b0620
861375sevelamer carbonate 800 MG Powder for Oral SuspensionSCD3abc32fe-1bfc-4759-8f7c-36095e221b0620
861375sevelamer carbonate 0.8 GM Powder for Oral SuspensionSY3abc32fe-1bfc-4759-8f7c-36095e221b0620
861370sevelamer carbonate 2.4 GM Powder for Oral SuspensionSY3abc32fe-1bfc-4759-8f7c-36095e221b0620

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0955-1050-2700955105027270 TABLET, FILM COATED in 1 BOTTLE (0955-1050-27) 2018-02-010000-00-00NoNoCurrent