FDA.reportPublic FDA data

SEVELAMER CARBONATE

Product NDC
64380-872
11-digit product format
643800872
Labeler code
64380
Product ID
64380-872_6566b265-1cda-4f44-90c7-c2572591791a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sevelamer carbonate
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA211915
Marketing category
ANDA
Marketing start
2024-07-02
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
64380-872-04SEVELAMER CARBONATE30 in 1 BOTTLETABLET308
64380-872-67SEVELAMER CARBONATE270 in 1 BOTTLETABLET2708

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-872-67EA - Each64380-87246bdec0c-ef05-4f7d-842f-420e00ea9f9c12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-872SEVELAMER CARBONATE TABLET [STRIDES PHARMA SCIENCE LIMITED]6Current NDC, 2 package rows20240704_649e5b7b-aa2f-4975-8c00-01d647d35c01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749206sevelamer carbonate 800 MG Oral TabletPSN649e5b7b-aa2f-4975-8c00-01d647d35c018
749206sevelamer carbonate 800 MG Oral TabletSCD649e5b7b-aa2f-4975-8c00-01d647d35c018

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64380-872-046438008720430 TABLET in 1 BOTTLE (64380-872-04) 30 tablet2024-07-02NoNoHistorical
64380-872-6764380087267270 TABLET in 1 BOTTLE (64380-872-67) 270 tablet2024-07-02NoNoHistorical