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 15 of 47 · 934 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vamousse Lice TreatmentPEDICULICIDEAlliance Pharma Inc.75db3fab-5523-4880-e053-2a91aa0a925e2025-12-05WarningsExact identifier
unii: 451W47IQ8X
V HPANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOX, SULPHUREnergique, Inc.cba32ae8-45af-494c-ac1a-fea4b10f18602025-12-04WarningsExact identifier
unii: 451W47IQ8X
SEVELAMER CARBONATESEVELAMER CARBONATEAiPing Pharmaceutical, Inc.0cade89a-38ca-4072-97a0-be09c6e058f42025-12-04Warnings, Adverse reactionsExact identifier
rxcui: 749206
unii: 9YCX42I8IU
THE FLOWER REMEDY Happy HeartGENTIANELLA AMARELLA, ULEX EUROPAEUS, ILEX AQUIFOLIUM, LONICERA CAPRIFOLIUM, SINAPIS ARVENSIS, ORNITHOGALUM UMBELLATUM, CASTANEA SATIVA, SALIX VITELLINA, IGNATIA AMARA, NATRUM MURIATICUMThe Flower Remedy6decd8fe-7593-4421-926c-f924002400322025-12-03WarningsExact identifier
unii: 451W47IQ8X
BM BIO28 ICING SUGARCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited3e855f3b-c73d-a153-e063-6394a90ad63a2025-12-02WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro3e85a931-57f6-2a55-e063-6294a90ac1802025-12-02WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products BIO28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA: Bestmade Natural Products Micro3e46ee90-2c2c-0a70-e063-6294a90a576a2025-12-02WarningsExact identifier
unii: 451W47IQ8X
BM Nat MurNATRIUM MURIATICUMBM Private Limited37b12318-dff9-e32a-e063-6394a90a18e82025-12-02WarningsExact identifier
unii: 451W47IQ8X
BM Nat Mur Icing SugarNATRUM MURIATICUM ICING SUGARBM Private Limited37c27f80-7689-c5a1-e063-6294a90a619b2025-12-02WarningsExact identifier
unii: 451W47IQ8X
Walgreens SalineNASALWALGREEN COMPANY147e45c8-1e71-4c06-89f1-42e9f96833662025-12-01WarningsExact identifier
unii: 451W47IQ8X
Sterile Saline Mist MeijerSODIUM CHLORIDEMeijer, Inc.445c8f4f-0519-0764-e063-6294a90a8b392025-12-01WarningsExact identifier
unii: 451W47IQ8X
Walgreen SalineNASALWALGREENS CO.ee264d8b-0bb2-472a-907c-6a6291f154cd2025-11-26WarningsExact identifier
unii: 451W47IQ8X
Sevelamer CarbonateSEVELAMER CARBONATESanofi-Aventis U.S. LLC3abc32fe-1bfc-4759-8f7c-36095e221b062025-11-25Warnings, Adverse reactionsExact identifier
application number: NDA022318
application number: NDA022127
ndc (package): 0955-1054-90
ndc (package): 0955-1057-30
ndc (package): 0955-1052-90
ndc (package): 0955-1052-01
ndc (package): 0955-1050-27
ndc (package): 0955-1054-01
ndc (product): 0955-1057
ndc (product): 0955-1052
ndc (product): 0955-1054
ndc (product): 0955-1050
ndc11 (package): 00955105201
rxcui: 749206
rxcui: 861375
rxcui: 861370
spl id: 42bdb389-5550-487c-aed2-c4e3afd239c8
spl set id: 3abc32fe-1bfc-4759-8f7c-36095e221b06
unii: 9YCX42I8IU
RenvelaSEVELAMER CARBONATEGenzyme Corporatione6328460-a57b-450b-a48c-6dcd4b4763602025-11-25Warnings, Adverse reactionsExact identifier
application number: NDA022318
application number: NDA022127
rxcui: 749206
rxcui: 861375
rxcui: 861370
unii: 9YCX42I8IU
Natural Eyes Floaters ReliefCHELIDONIUM, EUPHRASIA, KALI SULPH, NATRUM MURIATICUM, PHOSPHORUS, PHYSOSTIGMA, SEPIA, SILICEATRP Company445dc831-195e-4b25-e063-6294a90a6efd2025-11-24WarningsExact identifier
unii: 451W47IQ8X
Vital Female Sexual EnergyAGNUS CASTUS, ARNICA MONTANA, AVENA SATIVA, CAULOPHYLLUM THALICTROIDES, CINCHONA OFFICINALIS, DAMIANA, HYPOPHYSIS SUIS, L-ARGININE, NATRUM MURIATICUM, ONOSMODIUM VIRGINIANUM, OOPHORINUM SUIS, PHOSPHORICUM ACIDUM, SEPIA, THUJA OCCIDENTALISLiddell Laboratories, Inc.1ca43c82-62b0-4191-81a4-27f7f94109dd2025-11-20WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEWalgreen Companyd112a344-33cc-41d3-bae6-492631ebdba72025-11-19WarningsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLCce0c8c6f-734a-400f-9b60-a3b1e263f25f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDE TABLETSKesin Pharma Corporation2f107592-10c5-ef3b-e063-6394a90a7c0a2025-11-17WarningsExact identifier
unii: 451W47IQ8X
ALUMIZENGARLIC, AVENA SATIVA FLOWERING TOP, BERBERIS VULGARIS ROOT BARK, ARCTIUM LAPPA ROOT, PHYTOLACCA AMERICANA ROOT, SOLIDAGO VIRGAUREA FLOWERING TOP, ALUMINUM OXIDE, SILVER NITRATE, BARIUM CARBONATE, BERYLLIUM, CADMIUM, COPPER, HYDROFLUORIC ACID, INDIUM, IODINE, LITHIUM CARBONATE, MERCURIUS SOLUBILIS, NICKEL CARBONATE HYDROXIDE TETRAHYDRATE, NITROUS OXIDE, LEAD, SELENIUM, STRONTIUM CARBONATE, TITANIUM, ARSENIC TRIOXIDE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED.Natural Creations, Inc.4760ab09-1141-4944-b840-804ae6d86d2d2025-11-13WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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