Sevelamer Carbonate

Product NDC
10135-660
11-digit product format
101350660
Labeler code
10135
Product ID
10135-660_8392ecf2-1e76-4396-aaa7-1d29367e0486
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevelamer Carbonate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA207288
Marketing category
ANDA
Marketing start
2018-05-01
Marketing end
0000-00-00
Substance
SEVELAMER CARBONATE
Active strength
800 mg/1
Pharmacologic classes
Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5085f16b-f856-182d-a646-425b62d3f565Product name620251118
86e7ef73-ca63-701e-e952-6c80aa5122b8Product name920210309

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-660-68Sevelamer Carbonate270 in 1 BOTTLETABLET, FILM COATED2701

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-660SEVELAMER CARBONATE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]1Legacy NDC, 1 package rows20180522_852938de-6381-4466-84ee-685d2005ff2a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749206sevelamer carbonate 800 MG Oral TabletPSN852938de-6381-4466-84ee-685d2005ff2a1
749206sevelamer carbonate 800 MG Oral TabletSCD852938de-6381-4466-84ee-685d2005ff2a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10135-660-6810135066068270 in 1 BOTTLEHistorical