FDA.reportPublic FDA data

Sevelamer Carbonate

Product NDC
55111-789
11-digit product format
551110789
Labeler code
55111
Product ID
55111-789_f4b7a1eb-7592-27f3-1316-50b7d2538cd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevelamer Carbonate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DR. REDDY'S LABORATORIES LIMITED
Application
ANDA206094
Marketing category
ANDA
Marketing start
2017-09-29
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
55111-789-11Sevelamer Carbonate25 in 1 CARTONTABLET, FILM COATED2515
55111-789-27Sevelamer Carbonate270 in 1 BOTTLETABLET, FILM COATED27015
55111-789-30Sevelamer Carbonate30 in 1 BOTTLETABLET, FILM COATED3015
55111-789-48Sevelamer Carbonate4 in 1 BLISTER PACKTABLET, FILM COATED415
55111-789-90Sevelamer Carbonate90 in 1 BOTTLETABLET, FILM COATED9015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-789-11EA - Each55111-789540b8d64-738b-421e-9ead-843d2ebc20f312019-01-24
55111-789-27EA - Each55111-789fee16caa-280b-4351-953a-2895e3b26e1512017-10-13
55111-789-48EA - Each55111-789185128cb-ffde-4546-abbd-debe749f99cc12019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-789SEVELAMER CARBONATE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED]14Current NDC, Legacy NDC, 5 package rows20230804_0085356d-5fec-3cce-2bd3-108be70e515d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749206sevelamer carbonate 800 MG Oral TabletPSN0085356d-5fec-3cce-2bd3-108be70e515d15
749206sevelamer carbonate 800 MG Oral TabletSCD0085356d-5fec-3cce-2bd3-108be70e515d15
749206sevelamer carbonate 800 MG Oral TabletPSN42fefb90-6941-4539-8f32-df18962234506
749206sevelamer carbonate 800 MG Oral TabletSCD42fefb90-6941-4539-8f32-df18962234506
749206sevelamer carbonate 800 MG Oral TabletPSN3779296e-35bc-5b03-e063-6294a90a02141
749206sevelamer carbonate 800 MG Oral TabletSCD3779296e-35bc-5b03-e063-6294a90a02141

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-789-115511107891125 BLISTER PACK in 1 CARTON (55111-789-11) / 4 TABLET, FILM COATED in 1 BLISTER PACK (55111-789-48) 25 blister pack2018-12-120000-00-00NoNoCurrent
55111-789-2755111078927270 TABLET, FILM COATED in 1 BOTTLE (55111-789-27) 2017-09-290000-00-00NoNoCurrent
55111-789-305511107893030 TABLET, FILM COATED in 1 BOTTLE (55111-789-30) 2017-09-290000-00-00NoNoCurrent
55111-789-48551110789484 in 1 BLISTER PACKHistorical
55111-789-905511107899090 TABLET, FILM COATED in 1 BOTTLE (55111-789-90) 2017-09-290000-00-00NoNoCurrent