FDA.reportPublic FDA data

NDC 65862-931-08 - SEVELAMER CARBONATE

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
65862-931
Requested NDC
65862-931-08
Package NDCs from labels
65862-931-08, 65862-931-90
Manufacturer
Aurobindo Pharma Limited
Effective date
2023-12-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SEVELAMER CARBONATE - Aurobindo Pharma LimitedAurobindo Pharma Limited2023-12-08Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-931-08SEVELAMER CARBONATE1 in 1 POUCHPOWDER, FOR SUSPENSION19
65862-931-90SEVELAMER CARBONATE90 in 1 CARTONPOWDER, FOR SUSPENSION909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-931SEVELAMER CARBONATE POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]9Current NDC, Legacy NDC, 2 package rows20231209_ea201bff-cdfb-4304-bdb1-d05c1dac2677.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-931-08EA - Each65862-93134dad3b5-a185-41ca-8863-6af624bb631112017-07-07
65862-931-90EA - Each65862-931de681506-dccd-4b28-8a3c-296d6e3db3f712017-07-07

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 1 of 3 · 53 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sevelamer CarbonateSEVELAMER CARBONATEBryant Ranch Prepack462a11b9-78a3-4d8b-ae5d-3d6528e4d7432026-08-27Warnings, Adverse reactionsExact identifier
unii: 9YCX42I8IU
SEVELAMER CARBONATESEVELAMER CARBONATENorthStar RxLLC5baf3742-5929-42f8-8865-6b3e92647d5b2026-07-16Warnings, Adverse reactionsExact identifier
rxcui: 861375
unii: 9YCX42I8IU
Sevelamer CarbonateSEVELAMER CARBONATEMacleods Pharmaceuticals Limited4c927d50-34a6-499b-b1c2-924d4eb739872026-07-10Warnings, Adverse reactionsExact identifier
unii: 9YCX42I8IU
Sevelamer CarbonateSEVELAMER CARBONATEMarp Pharma515ae758-ccba-5758-e063-6394a90a315b2026-06-17Warnings, Adverse reactionsExact identifier
unii: 9YCX42I8IU
SEVELAMER CARBONATESEVELAMER CARBONATEINSIGNAMEDEX LLC51ce2ed6-3acf-a6ea-e063-6294a90a21aa2026-05-22Warnings, Adverse reactionsExact identifier
unii: 9YCX42I8IU
SEVELAMER CARBONATESEVELAMER CARBONATEPD-Rx Pharmaceuticals, Inc.b72baeeb-b6f5-4fa1-bee8-9eb4bb74dc822026-04-17Warnings, Adverse reactionsExact identifier
unii: 9YCX42I8IU
Sevelamer carbonateSEVELAMER CARBONATEZydus Pharmaceuticals USA Inc.2ccf62c6-dbad-416d-8e02-631795bd75172026-03-18Warnings, Adverse reactionsExact identifier
unii: 9YCX42I8IU
Allergen IPOTASSIUM GLUCONATE, GLANDULA SUPRARENALIS BOVINE, HEPAR BOVINE, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUS, PEANUT, BLACK WALNUT, ENGLISH WALNUT, AMYGDALA AMARA, CASHEW, COCONUT, PECAN, BRAZIL NUT, TOMATO, SOLANUM TUBEROSUM, PIPER NIGRUM, EGGPLANT (SOLANUM MELONGENA), RAPE SEED OIL, LINUM USITATISSIMUM, SESAME SEED, CHEESE (STILTON), LAC VACCINUM, BEEF, LAMB, PORK, CHICKEN, EGG (WHOLE), PHASEOLUS, ALLIUM CEPA, APPLE, WHEAT, BANANA, STRAWBERRY, COD (GADUS MORHUA), TUNA (THUNNUS THYNNUS),BioActive Nutritional25e10444-a2cc-4f74-bf38-9852c273e5ca2026-03-06WarningsExact identifier
unii: 5EVU04N5QU
Sevelamer CarbonateSEVELAMER CARBONATEAvPAK7f701cb4-3089-375f-e053-2991aa0a51b92026-01-20Warnings, Adverse reactionsExact identifier
unii: 9YCX42I8IU
Amalgam 6003AMALGAMProfessional Complementary Health Formulas1af74f69-a23a-45a2-a20e-92bf8b0ccb222026-01-08WarningsExact identifier
unii: TTV12P4NEE
Artificial Sweetener Detox 6034ARTIFICIAL SWEETENER DETOXProfessional Complementary Health Formulas38f2ae0b-2b1f-4b49-934d-fe1556f84d932026-01-08WarningsExact identifier
unii: 96K6UQ3ZD4
Multi Food AntigensARSENICUM ALBUM, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), ALLIUM CEPA, ALLIUM SATIVUM, ALMOND, APIUM GRAVEOLENS, BETA VULGARIS, BRASSICA OLERACEA VAR. ITALICA, BRAZIL, CACAO, CAPSICUM ANNUUM, CASHEW, CICER ARIETINUM, CITRUS LIMONUM, COCONUT, COFFEA TOSTA, COLLAGEN, CORN, CUCUMIS SATIVUS, ENGLISH WALNUT, GLYCINE MAX, HEART (BOVINE), HEART (SUIS), LAC VACCINUM, LACTUCA SATIVA, LYCOPERSICUM ESCULENTUM, ORANGE, OXALICUM ACIDUM, PEANUT, PECAN, PHASEOLUS, PHASEOLUS VULGARIS, RAPHANUS SATIVUS, SESAME,Energique, Inc.a289e8a7-1188-43be-b34b-fe6d5ee09d1c2026-01-06WarningsExact identifier
unii: 5EVU04N5QU
Sevelamer carbonateSEVELAMER CARBONATENavinta LLCd2f0c283-3e9d-41db-bd4d-83bd21f2a0192026-01-01Warnings, Adverse reactionsExact identifier
unii: 9YCX42I8IU
Sevelamer CarbonateSEVELAMER CARBONATECardinal Health 107, LLC65184825-adce-480e-a4c3-b21e37656cf42025-12-19Warnings, Adverse reactionsExact identifier
unii: 9YCX42I8IU
SEVELAMER CARBONATESEVELAMER CARBONATEShandong Xinhua Pharmaceutical Co., Ltd.f6455fa3-ad53-f6fd-e053-2a95a90a67db2025-12-15Warnings, Adverse reactionsExact identifier
unii: 9YCX42I8IU
SEVELAMER CARBONATESEVELAMER CARBONATEAiPing Pharmaceutical, Inc.0cade89a-38ca-4072-97a0-be09c6e058f42025-12-04Warnings, Adverse reactionsExact identifier
unii: 9YCX42I8IU
Sevelamer CarbonateSEVELAMER CARBONATESanofi-Aventis U.S. LLC3abc32fe-1bfc-4759-8f7c-36095e221b062025-11-25Warnings, Adverse reactionsExact identifier
rxcui: 861375
rxcui: 861370
unii: 9YCX42I8IU
RenvelaSEVELAMER CARBONATEGenzyme Corporatione6328460-a57b-450b-a48c-6dcd4b4763602025-11-25Warnings, Adverse reactionsExact identifier
rxcui: 861375
rxcui: 861370
unii: 9YCX42I8IU
Histamine BalancerALLIUM CEPA, GALPHIMIA GLAUCA, SABADILLA, APIS MELLIFICA, ESTRADIOL, KALI SULPHURICUM, GLANDULA SUPRARENALIS (BOVINE), HEPAR (BOVINE), INTESTINE (SUIS), STOMACH (SUIS), HYPOTHALAMUS SUIS, LYMPH NODE (SUIS), AMBROSIA ARTEMISIAEFOLIA, CARBO VEGETABILIS, PEANUT, BLACK WALNUT, ENGLISH WALNUT, AMYGDALA AMARA, CASHEW, COCONUT, PECAN, BRAZIL NUT, TOMATO, SOLANUM TUBEROSUM, PIPER NIGRUM, EGGPLANT, RAPE SEED OIL, LINUM USITATISSIMUM, SESAME SEED, CHEESE (STILTON), LAC VACCINUM, BEEF, LAMB, PORK, CHICKEN, EGG,Nutritional Specialties, Inc.109b48f9-3588-49f0-ba02-397e09a477d12025-11-19WarningsExact identifier
unii: 5EVU04N5QU
Sevelamer CarbonateSEVELAMER CARBONATEMajor Pharmaceuticals42fefb90-6941-4539-8f32-df18962234502025-11-13Warnings, Adverse reactionsExact identifier
unii: 9YCX42I8IU

Reported adverse events (FAERS/openFDA)#

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