FDA.reportPublic FDA data

Renvela

Product NDC
58468-0130
11-digit product format
584680130
Labeler code
58468
Product ID
58468-0130_bf613bdb-81c6-402f-ab37-56a808bd9f65
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SEVELAMER CARBONATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Genzyme Corporation
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
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5085f16b-f856-182d-a646-425b62d3f565Product name620251118
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
86e7ef73-ca63-701e-e952-6c80aa5122b8Product name920210309
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58468-0130-1Renvela270 in 1 BOTTLETABLET, FILM COATED27047
58468-0130-2Renvela30 in 1 BOTTLETABLET, FILM COATED3047

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58468-0130-1EA - Each58468-01304b4c7620-ab03-422b-83f1-64d32735afa312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SEVELAMER CARBONATEACTIVE INGREDIENT9YCX42I8IURENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION]13
SEVELAMERACTIVE MOIETY941N5DUU5CRENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION]13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION]13
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION]13
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WRENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION]13
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION]13
PROPYLENE GLYCOL ALGINATEINACTIVE INGREDIENT26CD3J2R0CRENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION]13
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XRENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION]13
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION]13
ZINC STEARATEINACTIVE INGREDIENTH92E6QA4FVRENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION]13
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
58468-0130RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED [GENZYME CORPORATION]43Legacy NDC, 2 package rows20230926_e6328460-a57b-450b-a48c-6dcd4b476360.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861377Renvela 0.8 GM Powder for Oral SuspensionPSNe6328460-a57b-450b-a48c-6dcd4b47636047
861373Renvela 2.4 GM Powder for Oral SuspensionPSNe6328460-a57b-450b-a48c-6dcd4b47636047
749210Renvela 800 MG Oral TabletPSNe6328460-a57b-450b-a48c-6dcd4b47636047
861375sevelamer carbonate 0.8 GM Powder for Oral SuspensionPSNe6328460-a57b-450b-a48c-6dcd4b47636047
861370sevelamer carbonate 2.4 GM Powder for Oral SuspensionPSNe6328460-a57b-450b-a48c-6dcd4b47636047
749206sevelamer carbonate 800 MG Oral TabletPSNe6328460-a57b-450b-a48c-6dcd4b47636047
861373sevelamer carbonate 2400 MG Powder for Oral Suspension [Renvela]SBDe6328460-a57b-450b-a48c-6dcd4b47636047
749210sevelamer carbonate 800 MG Oral Tablet [Renvela]SBDe6328460-a57b-450b-a48c-6dcd4b47636047
861377sevelamer carbonate 800 MG Powder for Oral Suspension [Renvela]SBDe6328460-a57b-450b-a48c-6dcd4b47636047
861370sevelamer carbonate 2400 MG Powder for Oral SuspensionSCDe6328460-a57b-450b-a48c-6dcd4b47636047
749206sevelamer carbonate 800 MG Oral TabletSCDe6328460-a57b-450b-a48c-6dcd4b47636047
861375sevelamer carbonate 800 MG Powder for Oral SuspensionSCDe6328460-a57b-450b-a48c-6dcd4b47636047
861377Renvela 0.8 GM Powder for Oral SuspensionSYe6328460-a57b-450b-a48c-6dcd4b47636047
861373Renvela 2.4 GM Powder for Oral SuspensionSYe6328460-a57b-450b-a48c-6dcd4b47636047
861373Renvela 2400 MG Powder for Oral SuspensionSYe6328460-a57b-450b-a48c-6dcd4b47636047
749210Renvela 800 MG Oral TabletSYe6328460-a57b-450b-a48c-6dcd4b47636047
861377Renvela 800 MG Powder for Oral SuspensionSYe6328460-a57b-450b-a48c-6dcd4b47636047
861375sevelamer carbonate 0.8 GM Powder for Oral SuspensionSYe6328460-a57b-450b-a48c-6dcd4b47636047
861370sevelamer carbonate 2.4 GM Powder for Oral SuspensionSYe6328460-a57b-450b-a48c-6dcd4b47636047
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
749210Renvela 800 MG Oral TabletPSN0edd2144-50b5-40d7-a81f-5f7647adc32a2
749206sevelamer carbonate 800 MG Oral TabletPSN0edd2144-50b5-40d7-a81f-5f7647adc32a2
749210sevelamer carbonate 800 MG Oral Tablet [Renvela]SBD0edd2144-50b5-40d7-a81f-5f7647adc32a2
749206sevelamer carbonate 800 MG Oral TabletSCD0edd2144-50b5-40d7-a81f-5f7647adc32a2
749210Renvela 800 MG Oral TabletSY0edd2144-50b5-40d7-a81f-5f7647adc32a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58468-0130-158468013001270 TABLET, FILM COATED in 1 BOTTLE (58468-0130-1) 2009-08-120000-00-00NoNoCurrent
58468-0130-25846801300230 in 1 BOTTLEHistorical