FDA.reportPublic FDA data

SEVELAMER CARBONATE

Product NDC
65862-931
11-digit product format
658620931
Labeler code
65862
Product ID
65862-931_e8c6db3c-3509-4033-8161-555236328bed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SEVELAMER CARBONATE
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA207624
Marketing category
ANDA
Marketing start
2017-06-13
Substance
SEVELAMER CARBONATE
Active strength
2400 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 CARBONATE2400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9YCX42I8IU
Rxcui861370, 861375

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
65862-931-08SEVELAMER CARBONATE1 in 1 POUCHPOWDER, FOR SUSPENSION19
65862-931-90SEVELAMER CARBONATE90 in 1 CARTONPOWDER, FOR SUSPENSION909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-931-08EA - Each65862-93134dad3b5-a185-41ca-8863-6af624bb631112017-07-07
65862-931-90EA - Each65862-931de681506-dccd-4b28-8a3c-296d6e3db3f712017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-931SEVELAMER CARBONATE POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]9Current NDC, Legacy NDC, 2 package rows20231209_ea201bff-cdfb-4304-bdb1-d05c1dac2677.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861375sevelamer carbonate 0.8 GM Powder for Oral SuspensionPSNea201bff-cdfb-4304-bdb1-d05c1dac26779
861370sevelamer carbonate 2.4 GM Powder for Oral SuspensionPSNea201bff-cdfb-4304-bdb1-d05c1dac26779
861370sevelamer carbonate 2400 MG Powder for Oral SuspensionSCDea201bff-cdfb-4304-bdb1-d05c1dac26779
861375sevelamer carbonate 800 MG Powder for Oral SuspensionSCDea201bff-cdfb-4304-bdb1-d05c1dac26779
861375sevelamer carbonate 0.8 GM Powder for Oral SuspensionSYea201bff-cdfb-4304-bdb1-d05c1dac26779
861370sevelamer carbonate 2.4 GM Powder for Oral SuspensionSYea201bff-cdfb-4304-bdb1-d05c1dac26779

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-931-08658620931081 in 1 POUCHHistorical
65862-931-906586209319090 POUCH in 1 CARTON (65862-931-90) / 1 POWDER, FOR SUSPENSION in 1 POUCH (65862-931-08) 90 pouch2017-06-130000-00-00NoNoCurrent