Sevelamer Carbonate

Product NDC
71335-3021
11-digit product format
713353021
Labeler code
71335
Product ID
71335-3021_5c329e0c-2108-4e78-9cfb-46a153a7319d
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
71335-3021-1Sevelamer Carbonate50 in 1 BOTTLETABLET, FILM COATED50100
71335-3021-2Sevelamer Carbonate90 in 1 BOTTLETABLET, FILM COATED90100
71335-3021-3Sevelamer Carbonate100 in 1 BOTTLETABLET, FILM COATED100100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-3021-1EA - Each71335-30218f2c9f47-136d-4958-b5ea-dacd0a48484c12026-01-08
71335-3021-2EA - Each71335-302177a47e2e-f304-4da5-bf58-ea038ebff4a012026-01-08
71335-3021-3EA - Each71335-3021061eb975-07ea-4572-844a-7dcdd46d8a8e12026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749206sevelamer carbonate 800 MG Oral TabletPSN26307350-69bb-40c9-9d5b-e0be2c11d0df100
749206sevelamer carbonate 800 MG Oral TabletSCD26307350-69bb-40c9-9d5b-e0be2c11d0df100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-3021-17133530210150 TABLET, FILM COATED in 1 BOTTLE (71335-3021-1) 2025-12-04NoNoHistorical
71335-3021-27133530210290 TABLET, FILM COATED in 1 BOTTLE (71335-3021-2) 2025-12-04NoNoHistorical
71335-3021-371335302103100 TABLET, FILM COATED in 1 BOTTLE (71335-3021-3) 2025-12-04NoNoHistorical