NDC 58468-0132-01 - Renvela

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
58468-0132
Requested NDC
58468-0132-01
Package NDCs from labels
58468-0132-1, 58468-0132-2, 58468-0132-01
Manufacturer
Genzyme Corporation | Reed-Lane, Inc. | HVL Pharma UK Limited | Eurofins Biopharma Product Testing Ireland Limited | Rovi Pharma Industrial Services SA | Sanofi Winthrop Industrie | Genzyme Ireland Limited
Effective date
2025-11-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
RenvelaGenzyme Corporation | Reed-Lane, Inc. | HVL Pharma UK Limited | Eurofins Biopharma Product Testing Ireland Limited | Rovi Pharma Industrial Services SA | Sanofi Winthrop Industrie | Genzyme Ireland Limited2025-11-25HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58468-0132-1Renvela1 in 1 PACKETPOWDER, FOR SUSPENSION147
58468-0132-2Renvela90 in 1 CARTONPOWDER, FOR SUSPENSION9047

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58468-0132RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED [GENZYME CORPORATION]43Current NDC, Legacy NDC, 2 package rows20230926_e6328460-a57b-450b-a48c-6dcd4b476360.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58468-0132-1EA - Each58468-013253dd274e-b134-404c-a94b-d6f315ff03ee12012-07-24
58468-0132-2EA - Each58468-01320a9035ea-ca87-4f0d-abd1-b02b57e92e4e12012-07-24

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 7 of 47 · 934 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AdrenaparARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS SUIS, ARSENICUM IODATUM, CALCAREA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMEnergique, Inc.077a9171-283d-47b6-bddc-34c739f6d69d2026-03-27WarningsExact identifier
unii: 451W47IQ8X
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: 3NXW29V3WO
Buffer pHCHAMOMILLA, GRAPHITES, KALI CARBONICUM, KALI OXALICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, NUX VOMICA, RHEUM (PALMATUM), ROBINIA PSEUDOACACIANaturalCare2161a2e2-613d-4dac-a5f6-796d40e849d92026-03-25WarningsExact identifier
unii: 451W47IQ8X
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: 3NXW29V3WO
Reflux AwayABIES NIGRA, ANTIMONIUM CRUDUM, ARGENTUM NITRICUM, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLOCYNTHIS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICANaturalCare8a00a72f-60df-4477-b7b8-abb6355e34da2026-03-24WarningsExact identifier
unii: 451W47IQ8X
Worafy Gentle Eye WashSODIUM CHLORIDEShenzhen Shandian Jingling Technology Co., Ltd.4da864dc-e10c-1db9-e063-6394a90a09842026-03-22WarningsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDE HYPERTONICITYSODIUM CHLORIDEYYBA CORP439653b9-99b8-4799-8d67-4a2ada9c67832026-03-20WarningsExact identifier
unii: 451W47IQ8X
Sevelamer carbonateSEVELAMER CARBONATEZydus Pharmaceuticals USA Inc.2ccf62c6-dbad-416d-8e02-631795bd75172026-03-18Warnings, Adverse reactionsExact identifier
rxcui: 749206
unii: 9YCX42I8IU
Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 PercentSODIUM CHLORIDEAltaire Pharmaceuticals Inc.e13fd053-9420-490c-a43e-e14b0930cb4e2026-03-18WarningsExact identifier
unii: 451W47IQ8X
UniversaltoxALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, HORDEUM VULGARE, NASTURTIUM AQUATICUM, RAPHANUS SATIVUS, TRITICUM AESTIVUM, IODIUM, UBIDECARENONUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, MANGANESE GLUCONATE, ORYZA SATIVA, THYROIDINUM (SUIS), CALCAREA CARBONICA, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), RHUS TOX, CORTISONE ACETICUMBioActive Nutritional, Inc.ad454e8a-4f78-4aac-90d9-a3f26a6fbe422026-03-17WarningsExact identifier
unii: 451W47IQ8X
BM BIO27CALC PHOS, KALI PHOS, NAT MURBM Private Limited4d229815-05f4-27c5-e063-6394a90ac8652026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO1CALC PHOS, FERR PHOS, KALI PHOS, NAT MURBM Private Limited4d265d99-fdbb-5efb-e063-6394a90a89ac2026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.BM Private Limited4d26b4a9-ee27-6915-e063-6294a90a5d4d2026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO12FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.BM Private Limited4d2747ad-958e-63a1-e063-6294a90aea662026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDEVenture Healthcare Ltd31b812c9-fb0a-5ee0-e063-6294a90a03e12026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDEVenture Healthcare Ltd31b88e7c-eca0-5540-e063-6294a90a1b182026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDEVenture Healthcare Ltd31b8c3f4-e528-c69d-e063-6294a90a5a342026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDELaboratoire Unither31b7eb13-39c3-6f0e-e063-6394a90a40112026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDELaboratoire Unither31b8bb9c-d30f-152f-e063-6394a90a52082026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDELaboratoire Unither31b8dcbd-9e6b-1edc-e063-6394a90aac732026-03-16WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.