FDA.reportPublic FDA data

Sevelamer Carbonate

Product NDC
72162-2499
11-digit product format
721622499
Labeler code
72162
Product ID
72162-2499_a111b64e-c229-4213-bae7-48bd2a42f2c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevelamer Carbonate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206100
Marketing category
ANDA
Marketing start
2023-04-19
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
86e7ef73-ca63-701e-e952-6c80aa5122b8Product name920210309

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2499-1Sevelamer Carbonate100 in 1 BOTTLETABLET, FILM COATED100101
72162-2499-2Sevelamer Carbonate270 in 1 BOTTLETABLET, FILM COATED270101
72162-2499-4Sevelamer Carbonate50 in 1 BOTTLETABLET, FILM COATED50101
72162-2499-9Sevelamer Carbonate90 in 1 BOTTLETABLET, FILM COATED90101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2499-1EA - Each72162-24995238e446-be51-4bec-901b-7aef731dfce812025-06-13
72162-2499-2EA - Each72162-24992a185afd-145b-4001-b4cf-13cd2abac2c812025-06-13
72162-2499-4EA - Each72162-24999c709934-f086-4e7c-9843-58512f06627e12025-06-13
72162-2499-9EA - Each72162-249902933484-a612-4366-bfce-d58db9f514a712025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2499SEVELAMER CARBONATE TABLET, FILM COATED [BRYANT RANCH PREPACK]100Current NDC, 4 package rows20250519_462a11b9-78a3-4d8b-ae5d-3d6528e4d743.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749206sevelamer carbonate 800 MG Oral TabletPSN462a11b9-78a3-4d8b-ae5d-3d6528e4d743101
749206sevelamer carbonate 800 MG Oral TabletSCD462a11b9-78a3-4d8b-ae5d-3d6528e4d743101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2499-172162249901100 TABLET, FILM COATED in 1 BOTTLE (72162-2499-1) 2025-05-15NoNoHistorical
72162-2499-272162249902270 TABLET, FILM COATED in 1 BOTTLE (72162-2499-2) 2025-05-15NoNoHistorical
72162-2499-47216224990450 TABLET, FILM COATED in 1 BOTTLE (72162-2499-4) 2025-05-15NoNoHistorical
72162-2499-97216224990990 TABLET, FILM COATED in 1 BOTTLE (72162-2499-9) 2025-05-15NoNoHistorical