FDA.reportPublic FDA data

NDC 68094-034-59 - 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
68094-034
Requested NDC
68094-034-59
Package NDCs from labels
68094-034-59, 68094-034-64
Manufacturer
Precision Dose, Inc.
Effective date
2025-08-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sevelamer Carbonate - Precision Dose, Inc.Precision Dose, Inc.2025-08-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68094-034-59Sevelamer Carbonate10 in 1 BLISTER PACKTABLET, FILM COATED104
68094-034-64Sevelamer Carbonate9 in 1 CARTONTABLET, FILM COATED94

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-034SEVELAMER CARBONATE TABLET, FILM COATED [PRECISION DOSE, INC.]3Current NDC, Legacy NDC, 2 package rows20241228_09b5e422-18c9-49dc-be3d-5d24648184af.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-034-59EA - Each68094-034b81b29e4-5866-49a3-a907-2ba8acdfc65e12021-07-15
68094-034-64EA - Each68094-0347432d029-cb11-4f32-8342-6c6cca34344c12021-07-15

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 32 of 40 · 788 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Systane ULTRAPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.a5c1c194-3db5-4f18-9cd1-97f7f84c3cff2023-12-15WarningsExact identifier
unii: 6DC9Q167V3
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.7eaa93ca-c843-4c89-921b-c76659410dce2023-12-14WarningsExact identifier
unii: 6DC9Q167V3
GenTeal Tears Gel DropsPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.84388a75-9d11-48ce-bf5a-88f0580d2d032023-12-14WarningsExact identifier
unii: 6DC9Q167V3
SEVELAMER CARBONATESEVELAMER CARBONATEAurobindo Pharma Limitedea201bff-cdfb-4304-bdb1-d05c1dac26772023-12-08Warnings, Adverse reactionsExact identifier
unii: 9YCX42I8IU
TerrestristatALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, ARALIA QUINQUEFOLIA, NATRUM CARBONICUM, THYROIDINUM (SUIS), CEREBRUM SUIS, PINEAL GLAND (SUIS), RHODODENDRON CHRYSANTHUM, AGATE, ARGENTUM NITRICUM, CADMIUM IODATUM, CALCAREA PHOSPHORICA, COFFEA CRUDA, CUPRUM METALLICUM, MERCURIUS CORROSIVUS, PHOSPHORICUM ACIDUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, RADIUM BROMATUM, CARCINOSIN, TARENTULA CUBENSIS, X-RAY, HOLMIUM METALLICUM, URANIUM NITRICUM.Energique, Inc.9bd83312-6872-4e39-b7ff-bbeb69015d802023-11-17WarningsExact identifier
unii: ETJ7Z6XBU4
Silica marinaSILICON DIOXIDEBoiron81442e86-bef4-4992-e053-2a91aa0a24532023-11-15Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d2b8f2-dce0-c136-e053-2991aa0a0fdb2023-11-15Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d31d98-dd71-870e-e053-2991aa0a0ce72023-11-15Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d3ffad-5be4-700a-e053-2991aa0a1cc92023-11-15Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d3206e-a893-3f0c-e053-2991aa0a149f2023-11-15Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d3d6ca-8b63-2e63-e053-2991aa0a0e052023-11-15Exact identifier
unii: ETJ7Z6XBU4
CV TOXCOCHLEARIA ARMORACIA, ECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PROPOLIS, GLANDULA SUPRARENALIS BOVINE, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, MORBILLINUM, POLIOMYELITIS NOSODE, HEPATITIS B NOSODE, COXSACKIE B1 NOSODE, CYTOMEGALOVIRUS NOSODE, COXSACKIE B4 NOSODE, EPSTEIN BARR VIRUS NOSODEBioActive Nutritional, Inc.8ef2fb5c-1b24-46a1-8d21-a78ce0a34a872023-11-07WarningsExact identifier
unii: ETJ7Z6XBU4
Sevelamer carbonateSEVELAMER CARBONATEZydus Pharmaceuticals USA Inc.71f61492-8971-424a-8415-dfd2e15d05d92023-11-07Warnings, Adverse reactionsExact identifier
rxcui: 749206
unii: 9YCX42I8IU
Sevelamer CarbonateSEVELAMER CARBONATEAmneal Pharmaceuticals LLC94d8cfb1-ff2a-4956-8954-17635ac505d92023-11-05Warnings, Adverse reactionsExact identifier
application number: ANDA207288
ndc (product): 65162-058
rxcui: 749206
spl id: 53f81fb7-7bbc-430f-a2e4-841b58e2cb7c
spl set id: 94d8cfb1-ff2a-4956-8954-17635ac505d9
unii: 9YCX42I8IU
Leg Cramps-SwellingECHINACEA, ARGENTUM NITRICUM, BRYONIA, CALCAREA CARBONICA, COLOCYNTHIS, CONVALLARIA MAJALIS, CROTALUS HORRIDUS, CUPRUM METALLICUM, DIGITALIS , GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, LATHYRUS SATIVUS, LILIUM TIGRINUM, MAGNESIA PHOSPHORICA, NUX VOMICA, RHUS TOXICODENDRON, SILICEA, STRAMONIUM, VERATRUM VIRIDE, ELAPSNewton Laboratories, Inc.9c31d465-caac-3a02-e053-2a95a90adb3b2023-11-03WarningsExact identifier
unii: ETJ7Z6XBU4
Thymus SarcodeECHINACEA PURPUREA, MYRISTICA SEBIFERA, BELLADONNA, CALCAREA SULPHURICA, THYMUS (OVINE), ARSENICUM ALBUM, SILICEA, SULPHUR IODATUM, CALCAREA FLUORICA, HEPAR SULPHURIS CALCAREUM, LACHESIS MUTUSNutritional Specialties, Inc.2dfda48f-5795-4b98-8bb2-bf65273e89202023-11-01WarningsExact identifier
unii: ETJ7Z6XBU4
Mineffect skin protectantALUMINA, CALCAREA SILICATA, MAGNESIA SULPHURICA, SILICEA, SULPHUR, TITANIUM METALLICUM, ZINCUM METALLICUMKadesh Incoporation Co,Ltd84a86989-bb7c-4f96-8cc0-d676264845322023-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
Mineffect nasal mistCALCAREA SILICATA, SILICEA, SULPHUR, NATRUM MURIATICUM, FERRUM METALLICUM, FERRUM PHOSPHORICUM, PHOSPHORUS, FERRUM MURIATICUM, TITANIUM METALLICUM,Kadesh Incoporation Co,Ltd3a29bf95-a8a3-4517-aedf-0cd4a91b349c2023-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
Mineffect acid indigestion and heartburn reliefALUMINA, CALCAREA SILICATA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, MAGNESIA MURIATICA, NATRUM NITRICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUMKadesh Incoporation Co,Ltd048367ff-a9bb-46a3-a835-aa3ab391eee42023-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
Mineffect hangover reliefALUMINA SILICATA, CALCAREA SILICATA, SILICEA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, FERRUM MURIATICUM, SULPHUR, PHOSPHORUSKadesh Incoporation Co,Ltdc9821e87-1e8d-48ab-8821-32e7e660309a2023-10-31WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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