FDA.reportPublic FDA data

NDC 65862-930-08 - 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
65862-930
Requested NDC
65862-930-08
Package NDCs from labels
65862-930-08, 65862-930-90
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
65862-930-08SEVELAMER CARBONATE1 in 1 POUCHPOWDER, FOR SUSPENSION19
65862-930-90SEVELAMER CARBONATE90 in 1 CARTONPOWDER, FOR SUSPENSION909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-930SEVELAMER 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
65862-930-08EA - Each65862-930fe6db9d2-ca6f-41c5-9d8d-c5a08b772b5712017-07-07
65862-930-90EA - Each65862-930dc1c68b4-86c2-4b3b-b10b-558caf59c40112017-07-07

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 3 of 3 · 53 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sevelamer CarbonateSEVELAMER CARBONATEAurobindo Pharma Limitedab0cd45f-0c4b-4ce7-bf8e-5f98d43feaab2024-04-04Warnings, Adverse reactionsExact identifier
unii: 9YCX42I8IU
SEVELAMER CARBONATESEVELAMER CARBONATEAurobindo Pharma Limitedea201bff-cdfb-4304-bdb1-d05c1dac26772023-12-08Warnings, Adverse reactionsExact identifier
application number: ANDA207624
ndc (package): 65862-930-90
ndc (package): 65862-931-08
ndc (package): 65862-930-08
ndc (package): 65862-931-90
ndc (product): 65862-930
ndc (product): 65862-931
ndc11 (package): 65862093008
rxcui: 861375
rxcui: 861370
spl id: e8c6db3c-3509-4033-8161-555236328bed
spl set id: ea201bff-cdfb-4304-bdb1-d05c1dac2677
unii: 9YCX42I8IU
Sevelamer carbonateSEVELAMER CARBONATEZydus Pharmaceuticals USA Inc.71f61492-8971-424a-8415-dfd2e15d05d92023-11-07Warnings, Adverse reactionsExact identifier
unii: 9YCX42I8IU
Sevelamer CarbonateSEVELAMER CARBONATEAmneal Pharmaceuticals LLC94d8cfb1-ff2a-4956-8954-17635ac505d92023-11-05Warnings, Adverse reactionsExact identifier
unii: 9YCX42I8IU
Anubis BarcelonaDMAEANUBIS COSMETICS SLf22b212d-d21d-5984-e053-2995a90a683e2023-09-01WarningsExact identifier
unii: TTV12P4NEE
Anubis BarcelonaDMAE, ZIRHAFIRMANUBIS COSMETICS SLf2274f8c-08aa-eb02-e053-2a95a90a39982023-09-01WarningsExact identifier
unii: TTV12P4NEE
Anubis BarcelonaPROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOLANUBIS COSMETICS SLebdddcec-f5da-51fe-e053-2995a90a61672023-09-01WarningsExact identifier
unii: TTV12P4NEE
Sevelamer carbonateSEVELAMER CARBONATECipla USA Inc.134f32c1-b5d5-44d0-9da5-85033e99320a2023-01-18Warnings, Adverse reactionsExact identifier
unii: 9YCX42I8IU
sevelamer carbonateSEVELAMER CARBONATEAmneal Pharmaceuticals of New York LLCda5239fe-060b-4469-95ac-173adec43b9c2020-12-31Warnings, Adverse reactionsExact identifier
rxcui: 861375
rxcui: 861370
unii: 9YCX42I8IU
Sevelamer carbonateSEVELAMER CARBONATEExelan Pharmaceuticals Inc.f8947f65-57be-4af7-b0e7-17666f496d012020-10-09Warnings, Adverse reactionsExact identifier
unii: 9YCX42I8IU
Sevelamer Carbonate for Oral SuspensionSEVELAMER CARBONATE FOR ORAL SUSPENSIONDr. Reddys Laboratories Incde172c3d-17eb-3489-35fb-370a0893b6632020-05-20Warnings, Adverse reactionsExact identifier
rxcui: 861375
rxcui: 861370
unii: 9YCX42I8IU
Sevelamer carbonateSEVELAMER CARBONATECipla USA Inc.f63450bd-d075-4810-a277-e8bc41e4a5af2018-12-19Warnings, Adverse reactionsExact identifier
unii: 9YCX42I8IU
Sevelamer carbonateSEVELAMER CARBONATEExelan Pharmaceuticals Inc.568b8558-6117-4c2f-aabf-86e567b388632018-11-29Warnings, Adverse reactionsExact identifier
unii: 9YCX42I8IU

Reported adverse events (FAERS/openFDA)#

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