FDA.reportPublic FDA data

Sevelamer Carbonate

Product NDC
65862-921
11-digit product format
658620921
Labeler code
65862
Product ID
65862-921_761597e6-1a2e-48e7-b657-c3fa781b4f6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevelamer Carbonate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA207179
Marketing category
ANDA
Marketing start
2017-07-17
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
86e7ef73-ca63-701e-e952-6c80aa5122b8Product name920210309
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-921-18Sevelamer Carbonate180 in 1 BOTTLETABLET, FILM COATED18011
65862-921-27Sevelamer Carbonate270 in 1 BOTTLETABLET, FILM COATED27011
65862-921-30Sevelamer Carbonate30 in 1 BOTTLETABLET, FILM COATED3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-921-27EA - Each65862-921d8941fa7-5533-4f5b-a980-7ff16e29130712017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-921SEVELAMER CARBONATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]11Current NDC, Legacy NDC, 3 package rows20240406_ab0cd45f-0c4b-4ce7-bf8e-5f98d43feaab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749206sevelamer carbonate 800 MG Oral TabletPSNab0cd45f-0c4b-4ce7-bf8e-5f98d43feaab11
749206sevelamer carbonate 800 MG Oral TabletPSNccfde4dd-b258-4baf-995b-a24bed8c84d711
749206sevelamer carbonate 800 MG Oral TabletSCDab0cd45f-0c4b-4ce7-bf8e-5f98d43feaab11
749206sevelamer carbonate 800 MG Oral TabletSCDccfde4dd-b258-4baf-995b-a24bed8c84d711
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 TabletPSN07b709fd-a2a1-4ff1-ad19-827d38e845625
749206sevelamer carbonate 800 MG Oral TabletSCD07b709fd-a2a1-4ff1-ad19-827d38e845625

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-921-1865862092118180 TABLET, FILM COATED in 1 BOTTLE (65862-921-18) 2017-07-170000-00-00NoNoCurrent
65862-921-2765862092127270 TABLET, FILM COATED in 1 BOTTLE (65862-921-27) 2017-07-170000-00-00NoNoCurrent
65862-921-306586209213030 TABLET, FILM COATED in 1 BOTTLE (65862-921-30) 2017-07-170000-00-00NoNoCurrent