FDA.reportPublic FDA data

Sevelamer Carbonate

Product NDC
0904-6707
11-digit product format
009046707
Labeler code
0904
Product ID
0904-6707_861910dd-653c-4652-b0e8-e78fa95ab8d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevelamer Carbonate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA206094
Marketing category
ANDA
Marketing start
2017-09-29
Marketing end
2026-12-31
Substance
SEVELAMER CARBONATE
Active strength
800 mg/1
Pharmacologic classes
Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sevelamer Carbonate

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
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
0904-6707-06Sevelamer Carbonate50 in 1 CARTONTABLET, FILM COATED506
0904-6707-06Sevelamer Carbonate1 in 1 BLISTER PACKTABLET, FILM COATED16
0904-6707-82Sevelamer Carbonate1 in 1 BLISTER PACKTABLET, FILM COATED16
0904-6707-82Sevelamer Carbonate100 in 1 CARTONTABLET, FILM COATED1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6707-06EA - Each0904-67077060f3d0-b44e-42da-aca9-7066907a3e8a12020-01-03
0904-6707-82EA - Each0904-6707602ec453-c282-4640-a699-d39d6d6a1ff012020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6707SEVELAMER CARBONATE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 4 package rows20250529_42fefb90-6941-4539-8f32-df1896223450.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749206sevelamer carbonate 800 MG Oral TabletPSN42fefb90-6941-4539-8f32-df18962234506
749206sevelamer carbonate 800 MG Oral TabletPSN65184825-adce-480e-a4c3-b21e37656cf46
749206sevelamer carbonate 800 MG Oral TabletSCD42fefb90-6941-4539-8f32-df18962234506
749206sevelamer carbonate 800 MG Oral TabletSCD65184825-adce-480e-a4c3-b21e37656cf46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6707-060090467070650 BLISTER PACK in 1 CARTON (0904-6707-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK50 blister pack2017-09-292026-12-31NoNoCurrent
0904-6707-8200904670782100 BLISTER PACK in 1 CARTON (0904-6707-82) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2017-09-292026-12-31NoNoCurrent