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 19 of 40 · 788 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sevelamer CarbonateSEVELAMER CARBONATEPrecision Dose, Inc.09b5e422-18c9-49dc-be3d-5d24648184af2025-08-11Warnings, Adverse reactionsExact identifier
application number: ANDA207288
ndc (package): 68094-034-64
ndc (package): 68094-034-59
ndc (product): 68094-034
ndc11 (package): 68094003459
rxcui: 749206
spl id: 85aed37f-f40b-4b15-92e5-037629c95e65
spl set id: 09b5e422-18c9-49dc-be3d-5d24648184af
unii: 9YCX42I8IU
Cloveden Vegan Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEAcuseplanet Inc3c04778b-9535-856e-e063-6294a90aa8682025-08-10WarningsExact identifier
unii: ETJ7Z6XBU4
Systane COMPLETEPROPYLENE GLYCOLAlcon Laboratories, Inc.2df0de02-a3e2-471a-9e10-040c3fba75fe2025-08-08WarningsExact identifier
unii: 6DC9Q167V3
Systane BalancePROPYLENE GLYCOLAlcon Laboratories, Inc.c7b1a03a-a5f2-409e-a34a-d6f166671de52025-08-07WarningsExact identifier
unii: 6DC9Q167V3
Schuessler Tissue Salts Silica Cleanser and Conditioner 12SILICEAMartin & Pleasance Pty Ltdf70dcf90-bde9-404d-9ede-4113553ccbff2025-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
Systane UltraPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.0537c23a-15f7-be64-1231-a6c93468e9a82025-07-30WarningsExact identifier
unii: 6DC9Q167V3
SystanePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.1d679d0f-cec2-a644-79cd-079607254bb92025-07-30WarningsExact identifier
unii: 6DC9Q167V3
Systane Ultra Preservative FreePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.751fb85f-6683-4b0a-a650-324d4a74c5de2025-07-30WarningsExact identifier
unii: 6DC9Q167V3
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.99b63d62-1cf0-4f28-8760-773917c2538a2025-07-29WarningsExact identifier
unii: 6DC9Q167V3
Cell SaltsCALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEANewton Laboratories, Inc.985a3341-0fe0-1dd6-e053-2a95a90ad2c52025-07-25WarningsExact identifier
unii: ETJ7Z6XBU4
SILICA MARINASILICON DIOXIDEBoiron3aada26e-6a8e-f545-e063-6394a90a9f802025-07-24Exact identifier
unii: ETJ7Z6XBU4
Cell SaltsCALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEANewton Laboratories, Inc.7a1b4e96-c96f-6424-e053-2991aa0aef302025-07-24WarningsExact identifier
unii: ETJ7Z6XBU4
Cell SaltsCALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEANewton Laboratories, Inc.7a1a9ef9-9a54-5f94-e053-2a91aa0ab4772025-07-24WarningsExact identifier
unii: ETJ7Z6XBU4
Smelling SaltsSMELLING SALTSShenzhen Weikeduo E-commerce Co., Ltd.377fa82a-dcbe-9ab6-e063-6394a90a63842025-07-18WarningsExact identifier
unii: 5138Q19F1X
SEVELAMER CARBONATESEVELAMER CARBONATEStrides Pharma Science Limited649e5b7b-aa2f-4975-8c00-01d647d35c012025-07-17Warnings, Adverse reactionsExact identifier
rxcui: 749206
unii: 9YCX42I8IU
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
DENTAL-CHORDACETICUM ACIDUM, AMMONIUM MURIATICUM, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CARBOLICUM ACIDUM, CITRUS LIMONUM, CUPRUM METALLICUM, FERRUM METALLICUM, GLYCYRRHIZA GLABRA, LAPPA MAJOR, MEDULLA OSSIS SUIS, MERCURIUS SOLUBILIS, MYRRHA, NATRUM FLUORATUM, PALLADIUM METALLICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SELENIUM METALLICUM, SILICEA, STANNUM METALLICUM, STAPHYSAGRIA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, X-RAY, ZINCUM OXYDATUMEnergetix Corporation6c9ba926-7c35-49fd-94d8-988ca0bb772c2025-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
EndocrinpathALFALFA, BORAGO OFFICINALIS, CALCAREA CARBONICA, CEANOTHUS AMERICANUS, CITRICUM ACIDUM, FUCUS VESICULOSUS, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYDROCOTYLE ASIATICA, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, PANCREAS SUIS, PHYTOLACCA DECANDRA, PITUITARUM POSTERIUM (BOVINE), SARSAPARILLA (SMILAX REGELII), SILICEA, SYZYGIUM JAMBOLANUM, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE)Energetix Corporation70f84941-b8a1-48f4-9c05-554e554f00492025-07-11WarningsExact identifier
unii: ETJ7Z6XBU4
Gluvelop SMELLING SALTSSMELLING SALTSShenzhen Nanjun Technology Co., Ltd398c26ec-5eba-1202-e063-6294a90a76c92025-07-09WarningsExact identifier
unii: 5138Q19F1X
SEVELAMER CARBONATESEVELAMER CARBONATEStrides Pharma Science Limitedc17bff97-8347-43f8-822e-1cb9736562b62025-07-09Warnings, Adverse reactionsExact identifier
unii: 9YCX42I8IU

Reported adverse events (FAERS/openFDA)#

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