Renagel

Product NDC
67544-656
11-digit product format
675440656
Labeler code
67544
Product ID
67544-656_7bba784e-b2dd-4662-a66d-09246be23c7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Renagel
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA021179
Marketing category
NDA
Marketing start
2008-06-06
Marketing end
0000-00-00
Substance
SEVELAMER HYDROCHLORIDE
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
67544-656-79Renagel2160 in 1 BOTTLE, PLASTICTABLET21601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-656RENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 1 package rows20140429_b27c1744-1d96-4f9f-b621-e24a795b7534.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857224sevelamer HCl 800 MG Oral TabletPSNb27c1744-1d96-4f9f-b621-e24a795b75341
857224sevelamer hydrochloride 800 MG Oral TabletSCDb27c1744-1d96-4f9f-b621-e24a795b75341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67544-656-79675440656792160 in 1 BOTTLE, PLASTICHistorical