FDA.reportPublic FDA data

Sevelamer Carbonate

Product NDC
50268-720
11-digit product format
502680720
Labeler code
50268
Product ID
50268-720_48d3c3e9-e4a2-5516-e063-6294a90a3dd3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevelamer Carbonate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA207288
Marketing category
ANDA
Marketing start
2019-01-14
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
50268-720-11Sevelamer Carbonate1 in 1 BLISTER PACKTABLET, FILM COATED15
50268-720-15Sevelamer Carbonate50 in 1 BOXTABLET, FILM COATED505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-720-11EA - Each50268-7205e42bc50-71e6-488c-8f54-c147c7de42d212019-03-12
50268-720-15EA - Each50268-720215c3ac0-147a-432d-b889-ecad1937003e12019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-720SEVELAMER CARBONATE TABLET, FILM COATED [AVPAK]3Current NDC, Legacy NDC, 2 package rows20240110_7f701cb4-3089-375f-e053-2991aa0a51b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749206sevelamer carbonate 800 MG Oral TabletPSN7f701cb4-3089-375f-e053-2991aa0a51b95
749206sevelamer carbonate 800 MG Oral TabletSCD7f701cb4-3089-375f-e053-2991aa0a51b95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-720-11502680720111 in 1 BLISTER PACKHistorical
50268-720-155026807201550 BLISTER PACK in 1 BOX (50268-720-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-720-11) 50 blister pack2019-01-140000-00-00NoNoCurrent