FDA.reportPublic FDA data

Sevelamer Carbonate

Product NDC
0955-1054
11-digit product format
009551054
Labeler code
0955
Product ID
0955-1054_42bdb389-5550-487c-aed2-c4e3afd239c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevelamer Carbonate
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Sanofi-Aventis U.S. LLC
Application
NDA022318
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-01-01
Substance
SEVELAMER CARBONATE
Active strength
2.4 g/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 CARBONATE2.4 g/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
0955-1054-01Sevelamer Carbonate1 in 1 PACKETPOWDER, FOR SUSPENSION120
0955-1054-90Sevelamer Carbonate90 in 1 BOXPOWDER, FOR SUSPENSION9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0955-1054-01EA - Each0955-1054b52b59aa-2aaf-4d81-a040-56c82a93715012018-02-20
0955-1054-90EA - Each0955-1054386f9b27-fd9b-4563-8b6e-e27e93a1ced412018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0955-1054SEVELAMER CARBONATE TABLET, FILM COATED SEVELAMER CARBONATE POWDER, FOR SUSPENSION [SANOFI-AVENTIS U.S. LLC]19Current NDC, Legacy NDC, 2 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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0955-1054-01009551054011 in 1 PACKETHistorical
0955-1054-900095510549090 PACKET in 1 BOX (0955-1054-90) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0955-1054-01) 90 packet2018-01-010000-00-00NoNoCurrent