FDA.reportPublic FDA data

Renvela

Product NDC
68151-5113
11-digit product format
681515113
Labeler code
68151
Product ID
68151-5113_9d9ca1be-5e19-4c38-8f65-ac46b4f426a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SEVELAMER CARBONATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Carilion Materials Management
Application
NDA022127
Marketing category
NDA
Marketing start
2009-08-12
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
E
Listing certified through
2018-12-31
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
68151-5113-12020-01-31C16284748780-19d75b9d0-cfc1-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Renvela safely and effectively. See full prescribing information for Renvela. Renvela (sevelamer carbonate) Tablet, Film Coated for Oral use Renvela (sevelamer carbonate) For Oral Suspension Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-5113-1Renvela1 in 1 PACKAGETABLET, FILM COATED13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SEVELAMER CARBONATEACTIVE INGREDIENT9YCX42I8IURENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
SEVELAMERACTIVE MOIETY941N5DUU5CRENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WRENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XRENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
ZINC STEARATEINACTIVE INGREDIENTH92E6QA4FVRENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-5113RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20160806_56ccbfc1-4763-46cd-b71c-d6753a4ad23e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749210Renvela 800 MG Oral TabletPSN56ccbfc1-4763-46cd-b71c-d6753a4ad23e3
749206sevelamer carbonate 800 MG Oral TabletPSN56ccbfc1-4763-46cd-b71c-d6753a4ad23e3
749210sevelamer carbonate 800 MG Oral Tablet [Renvela]SBD56ccbfc1-4763-46cd-b71c-d6753a4ad23e3
749206sevelamer carbonate 800 MG Oral TabletSCD56ccbfc1-4763-46cd-b71c-d6753a4ad23e3
749210Renvela 800 MG Oral TabletSY56ccbfc1-4763-46cd-b71c-d6753a4ad23e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-5113-1681515113011 in 1 PACKAGEHistorical