Sevelamer carbonate

Product NDC
76282-407
11-digit product format
762820407
Labeler code
76282
Product ID
76282-407_531e94a5-1e37-446c-879a-bafeedf64bd5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SEVELAMER CARBONATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Exelan Pharmaceuticals Inc.
Application
ANDA203860
Marketing category
ANDA
Marketing start
2017-11-08
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
86e7ef73-ca63-701e-e952-6c80aa5122b8Product name920210309

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-407-27Sevelamer carbonate270 in 1 BOTTLETABLET, FILM COATED2702

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-407-27EA - Each76282-40710b5579b-0219-4ced-a0b6-576a8288cc0212019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-407SEVELAMER CARBONATE TABLET, FILM COATED [EXELAN PHARMACEUTICALS INC.]2Current NDC, Legacy NDC, 1 package rows20181219_568b8558-6117-4c2f-aabf-86e567b38863.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749206sevelamer carbonate 800 MG Oral TabletPSN568b8558-6117-4c2f-aabf-86e567b388632
749206sevelamer carbonate 800 MG Oral TabletSCD568b8558-6117-4c2f-aabf-86e567b388632

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76282-407-2776282040727270 TABLET, FILM COATED in 1 BOTTLE (76282-407-27) 2017-11-080000-00-00NoNoCurrent