FDA.reportPublic FDA data

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67544-656-792020-01-31C16284748780-19d75b9d0-235f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Renagel safely and effectively. See full prescribing information for Renagel. Renagel (sevelamer hydrochloride) Tablet for Oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-656-79Renagel2160 in 1 BOTTLE, PLASTICTABLET21601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SEVELAMER HYDROCHLORIDEACTIVE INGREDIENTGLS2PGI8QGRENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SEVELAMERACTIVE MOIETY941N5DUU5CRENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357RENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WRENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4RENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302RENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APRENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RRENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

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