SEVELAMER CARBONATE

Product NDC
72789-562
11-digit product format
727890562
Labeler code
72789
Product ID
72789-562_4faaca2e-237f-58ee-e063-6394a90acd4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SEVELAMER CARBONATE
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA215998
Marketing category
ANDA
Marketing start
2025-12-15
Substance
SEVELAMER CARBONATE
Active strength
800 mg/1
Pharmacologic classes
Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SEVELAMER CARBONATE
Listing expiration
2027-12-31

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
72789-562-94SEVELAMER CARBONATE270 in 1 BOTTLE, PLASTICTABLET2702

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-562-94EA - Each72789-56251fbfc9a-d73c-468a-9534-f0a600b8757712026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749206sevelamer carbonate 800 MG Oral TabletPSNb72baeeb-b6f5-4fa1-bee8-9eb4bb74dc822
749206sevelamer carbonate 800 MG Oral TabletSCDb72baeeb-b6f5-4fa1-bee8-9eb4bb74dc822

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-562-9472789056294270 TABLET in 1 BOTTLE, PLASTIC (72789-562-94) 270 tablet2026-04-16NoNoCurrent