Sevelamer Carbonate

Product NDC
60687-328
11-digit product format
606870328
Labeler code
60687
Product ID
60687-328_1e7c0036-b057-e32a-e063-6394a90a6caf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevelamer Carbonate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA207179
Marketing category
ANDA
Marketing start
2017-08-22
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
60687-328-11Sevelamer Carbonate1 in 1 BLISTER PACKTABLET, FILM COATED17
60687-328-31Sevelamer Carbonate100 in 1 BOX, UNIT-DOSETABLET, FILM COATED1007
60687-328-33Sevelamer Carbonate1 in 1 BLISTER PACKTABLET, FILM COATED17
60687-328-65Sevelamer Carbonate50 in 1 BOX, UNIT-DOSETABLET, FILM COATED507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-328-11EA - Each60687-3283733e4f3-5b60-4cb3-ac8f-7b79ba7a53e312019-05-02
60687-328-31EA - Each60687-32851a23a44-48b5-435d-af3a-4cee632f9fbd12017-09-11
60687-328-33EA - Each60687-328a7407631-68db-481a-b785-32e882f515ad12017-09-11
60687-328-65EA - Each60687-328c5ae51f6-647b-45d7-9d4b-cb2aba91f30412019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-328SEVELAMER CARBONATE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]7Current NDC, Legacy NDC, 4 package rows20240731_bd0a89ab-91c4-42b3-aa88-1e3295d0d344.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749206sevelamer carbonate 800 MG Oral TabletPSNbd0a89ab-91c4-42b3-aa88-1e3295d0d3447
749206sevelamer carbonate 800 MG Oral TabletSCDbd0a89ab-91c4-42b3-aa88-1e3295d0d3447
749206sevelamer carbonate 800 MG Oral TabletPSN61d073ec-51a4-48c7-8762-25fdd00fe6ac4
749206sevelamer carbonate 800 MG Oral TabletSCD61d073ec-51a4-48c7-8762-25fdd00fe6ac4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-328-11606870328111 in 1 BLISTER PACKHistorical
60687-328-3160687032831100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-328-31) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-328-33) 100 blister pack2017-08-220000-00-00NoNoCurrent
60687-328-33606870328331 in 1 BLISTER PACKHistorical
60687-328-656068703286550 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-328-65) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-328-11) 50 blister pack2019-04-240000-00-00NoNoCurrent