FDA.reportPublic FDA data

SEVELAMER CARBONATE

Product NDC
72603-398
11-digit product format
726030398
Labeler code
72603
Product ID
72603-398_5baf3742-5929-42f8-8865-6b3e92647d5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SEVELAMER CARBONATE
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA207291
Marketing category
ANDA
Marketing start
2025-01-01
Substance
SEVELAMER CARBONATE
Active strength
.8 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 CARBONATE.8 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9YCX42I8IU
Rxcui861375

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
72603-398-01SEVELAMER CARBONATE1 in 1 PACKETPOWDER, FOR SUSPENSION11
72603-398-02SEVELAMER CARBONATE90 in 1 CARTONPOWDER, FOR SUSPENSION901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-398-01EA - Each72603-398f6432e1f-b6c5-4836-a991-583e7a4eb9d012025-02-10
72603-398-02EA - Each72603-3983492118f-7cca-4a68-8a73-3eec05fd87a712025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-398SEVELAMER CARBONATE POWDER, FOR SUSPENSION [NORTHSTAR RXLLC]1Current NDC, 2 package rows20250101_5baf3742-5929-42f8-8865-6b3e92647d5b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861375sevelamer carbonate 0.8 GM Powder for Oral SuspensionPSN5baf3742-5929-42f8-8865-6b3e92647d5b1
861375sevelamer carbonate 800 MG Powder for Oral SuspensionSCD5baf3742-5929-42f8-8865-6b3e92647d5b1
861375sevelamer carbonate 0.8 GM Powder for Oral SuspensionSY5baf3742-5929-42f8-8865-6b3e92647d5b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-398-01726030398011 in 1 PACKETHistorical
72603-398-027260303980290 PACKET in 1 CARTON (72603-398-02) / 1 POWDER, FOR SUSPENSION in 1 PACKET (72603-398-01) 90 packet2025-01-01NoNoHistorical