FDA.reportPublic FDA data

NDC 0955-1052-01 - 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
0955-1052
Requested NDC
0955-1052-01
Package NDCs from labels
0955-1052-01, 0955-1052-90
Manufacturer
Sanofi-Aventis U.S. LLC | Reed-Lane, Inc. | HVL Pharma UK Limited | Eurofins Biopharma Product Testing Ireland Limited | Rovi Pharma Industrial Services SA | 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
Sevelamer CarbonateSanofi-Aventis U.S. LLC | Reed-Lane, Inc. | HVL Pharma UK Limited | Eurofins Biopharma Product Testing Ireland Limited | Rovi Pharma Industrial Services SA | Genzyme Ireland Limited2025-11-25HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0955-1052-01Sevelamer Carbonate1 in 1 PACKETPOWDER, FOR SUSPENSION120
0955-1052-90Sevelamer Carbonate90 in 1 BOXPOWDER, FOR SUSPENSION9020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0955-1052SEVELAMER CARBONATE TABLET, FILM COATED SEVELAMER CARBONATE POWDER, FOR SUSPENSION [SANOFI-AVENTIS U.S. LLC]19Current NDC, Legacy NDC, 2 package rows20250213_3abc32fe-1bfc-4759-8f7c-36095e221b06.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0955-1052-01EA - Each0955-1052dcad97b7-dee7-42c3-8524-f7b68839179d12018-02-20
0955-1052-90EA - Each0955-1052b5de286b-ebc3-4788-8949-930135c2120f12018-02-20

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 14 of 47 · 934 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Woman PowerAGNUS, ARALIA QUIN, ARNICA, DAMIANA, LACTUCA, NAT MUR, ONOSMODIUM VIRGINIANUM, OOPHORINUM, PHOSPHORICUM AC, PITUITARUM POSTERIUM, SALIX NIG, SEPIA, THUJA OCCEight and Company L.L.C614d47de-742b-4944-89c8-59f2f58dc8b92025-12-17WarningsExact identifier
unii: 451W47IQ8X
PSORIASIS HPARSENICUM ALBUM, ARSENICUM IODATUM, BORAX, CALCAREA CARBONICA, GRAPHITES, MEZEREUM, PROTEUS, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, SEPIA, SILICEA, SULPHUR, THYROIDINUMNatural Creations, Inc.d2522637-fd16-4246-90d8-f90fb224550e2025-12-16WarningsExact identifier
unii: 451W47IQ8X
MoodARALIA QUIN, CIMICIFUGA, SPIGELIA ANTH, ARG NIT, ARSENICUM ALB, AURUM MET, IGNATIA AMARA, LACHESIS, LYCOPODIUM, NAT MUR, PHOSPHORICUM AC, PLATINUM MET, PULSATILLA, SEPIA, THUJA OCCNatural Creations, Inc7f143f30-2b72-4e6c-985c-8d3a485dbdb42025-12-16WarningsExact identifier
unii: 451W47IQ8X
IODIUM HPBARIUM CARBONATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, FUCUS VESICULOSUS, IODINE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED, THYROIDNatural Creations, Inc.9353d604-e168-4df1-9726-e965c9fc2c782025-12-16WarningsExact identifier
unii: 451W47IQ8X
SINUS HPAMBROSIA ARTEMISIIFOLIA, ARSENIC TRIOXIDE, CALCIUM SULFIDE, POTASSIUM DICHROMATE, POTASSIUM SULFATE, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLUBILIS, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, THUJA OCCIDENTALIS LEAFY TWIGNatural Creations, Inc.f017da22-74c2-40f4-adcc-5e84b6ea52912025-12-16WarningsExact identifier
unii: 451W47IQ8X
Hydrate 1BERBERISAQUI,BETAVULGARIS,BOLDO,CARDUUSMARIANUS,CHELIDONIUMMAJUS,ELEUTHEROCOCCUS SENTICOSUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,TARAXACUMOFFICINALE,XANTHOXYLUMFRAXINEUM,ULMUSFULVA,GLYCYRRHIZAGLABRA,GETTYSBURGAQUA,WILDBADAQUA,CARLSBADAQUA,ATP,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUA,HYDROGENNatural Creations, Inc189bc53c-5d75-48df-a74e-cfff2d08d3a92025-12-16WarningsExact identifier
unii: 451W47IQ8X
Hydrate 2BERBERISAQUIFOLIUM,BETAVULGARIS,BOLDO,CHELIDONIUMMAJUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,CARDUUSMARIANUS,TARAXACUMOFFICINALE,AVENASATIVA,ELEUTHEROCOCCUSSENTICOSUS,XANTHOXYLUMFRAXINEUM,EQUISETUMHYEMALE,HYPERICUMPERFORATUM,ULMUSFULVA,GETTYSBURGAQUA,GLYCYRRHIZAGLABRA,WILDBADAQUA,CARLSBADAQUA,ATP,HYDROGEN,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUANatural Creations, Inc1122605f-715e-4f12-9d9d-a20442f9cd452025-12-16WarningsExact identifier
unii: 451W47IQ8X
Migraine Headache TherapyATROPA BELLADONNA - BRYONIA ALBA ROOT - BLACK COHOSH - ARABICA COFFEE BEAN - NITROGLYCERIN - IRIS VERSICOLOR ROOT - SODIUM CHLORIDE -TRP Company317d3f42-783e-02b7-e054-00144ff88e882025-12-15WarningsExact identifier
unii: 451W47IQ8X
Artificial TearsGLYCERINNuCare Pharmaceuticals,Inc.97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d2025-12-15WarningsExact identifier
unii: 3NXW29V3WO
Mucus and Sinus Mucus and Sinus Symptom ReliefBRYONIA ALBA, HYDRASTIS CANADENSIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA PRATENSIS, SILICEA, STANNUM METALLICUM, THUJA OCCIDENTALIS, ZINCUM GLUCONICUMTRP Company2a42c4a3-9486-9b29-e063-6294a90a7c702025-12-15WarningsExact identifier
unii: 451W47IQ8X
Natural Relief Cold and Flu Plus ZincALLIUM CEPA, ARSENICUM ALBUM, BRYONIA ALBA, EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, NATRUM MURIATICUM, NUX VOMICA, SILICEA, SULPHUR, ZINCUM GLUCONICUMTRP Company2a352cf2-48fb-4862-e063-6294a90a2eeb2025-12-15WarningsExact identifier
unii: 451W47IQ8X
Natural Relief Cough and Congestion Cough and Congestion Symptom ReliefANTIMONIUM TARTARICUM, COCCUS CACTI, CUPRUM METALLICUM, DROSERA ROTUNDIFOLIA, ECHINACEA ANGUSTIFOLIA, KALI CARBONICUM, MEPHITIS MEPHITICA, NATRUM MURIATICUM, RUMEX CRISPUS, ZINCUM GLUCONICUMTRP Company2a430f41-bd33-32af-e063-6394a90ae8012025-12-15WarningsExact identifier
unii: 451W47IQ8X
SEVELAMER CARBONATESEVELAMER CARBONATEShandong Xinhua Pharmaceutical Co., Ltd.f6455fa3-ad53-f6fd-e053-2a95a90a67db2025-12-15Warnings, Adverse reactionsExact identifier
rxcui: 749206
unii: 9YCX42I8IU
Sinu-RiteGLYCYRRHIZA, KALI BIC, NAT MUR, PULSATILLA, SAMBUCUSSILVER STAR BRANDSb79e177c-6bd7-2f9a-e053-2a95a90abedb2025-12-12WarningsExact identifier
unii: 451W47IQ8X
HEADACHE HPSILVER NITRATE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, GELSEMIUM SEMPERVIRENS ROOT, NITROGLYCERIN, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, MELILOTUS OFFICINALIS TOP, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, SPIGELIA ANTHELMIANatural Creations, Inc.c38b83f0-3918-4ef6-8dfd-48fe438e584a2025-12-12WarningsExact identifier
unii: 451W47IQ8X
Cell WellCALCIUM CARBONICA,CALCIUM FLUORATUM,CALCIUM PHOSPHORICUM,CALCIUM SULPHURICUM,FERRUM PHOSPHORICUM,KALIUM MURIATICUM,KALIUM PHOSPHORICUM,KALIUM SULPHURICUM,MAGNESIUM CARBONICA,MAGNESIUM PHOSPHORICUM,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAJoyWell Co LLC592c1f48-21c8-4ff5-8818-046662c9effe2025-12-11WarningsExact identifier
unii: 451W47IQ8X
SinuCleanseSODIUM BICARBONATE, SODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.beb842fa-2373-4f21-9631-ef20ee1245842025-12-10WarningsExact identifier
unii: 451W47IQ8X
All natural Saline Packets CareOneSODIUM BICARBONATE, SODIUM CHLORIDEFOODHOLD U.S.A.e32f105d-65cd-8095-e053-2995a90a9b6b2025-12-10WarningsExact identifier
unii: 451W47IQ8X
Rhinomel ManukaSODIUM CHLORIDEMelcare Biomedical Pty Ltd35a7ce7d-4a26-e3f0-e063-6294a90ad66f2025-12-09WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDESOLA Pharmaceuticals, LLC4d0bfd28-460a-48ba-bd17-cf75e56d62f42025-12-09Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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