FDA.reportPublic FDA data

Renagel

Product NDC
53808-0777
11-digit product format
538080777
Labeler code
53808
Product ID
53808-0777_5ec67fac-794f-4ca5-a5ef-6a0cf51565e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Renagel
Dosage form
TABLET
Route
ORAL
Labeler
DOH CENTRAL PHARMACY
Application
NDA021179
Marketing category
NDA
Marketing start
2009-07-01
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
86e7ef73-ca63-701e-e952-6c80aa5122b8Product name920210309

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0777-12020-01-31C16284748780-19d75b9d0-d912-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
53808-0777-1Renagel30 in 1 BLISTER PACKTABLET303

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SEVELAMER HYDROCHLORIDEACTIVE INGREDIENTGLS2PGI8QGRENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SEVELAMERACTIVE MOIETY941N5DUU5CRENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSE 2910 (15 CPS)INACTIVE INGREDIENT36SFW2JZ0WRENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSE 2910 (5 CPS)INACTIVE INGREDIENTR75537T0T4RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APRENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
WATERINACTIVE INGREDIENT059QF0KO0RRENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0777RENAGEL TABLET [DOH CENTRAL PHARMACY]3Legacy NDC, 1 package rows20170209_4a3b3dd8-9b4a-4a00-8178-eb8417195081.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857224sevelamer HCl 800 MG Oral TabletPSN4a3b3dd8-9b4a-4a00-8178-eb84171950813
857224sevelamer hydrochloride 800 MG Oral TabletSCD4a3b3dd8-9b4a-4a00-8178-eb84171950813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0777-15380807770130 in 1 BLISTER PACKHistorical