FDA.reportPublic FDA data

NDC 50090-2159-01 - Cefuroxime axetil

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
50090-2159
Requested NDC
50090-2159-01
Package NDCs from labels
50090-2159-0, 50090-2159-1, 50090-2159-01
Manufacturer
A-S Medication Solutions
Effective date
2024-09-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cefuroxime axetil - A-S Medication SolutionsA-S Medication Solutions2024-09-11Human Prescription Drug Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2159-02023-02-07C16284748780-1f386c649-b15d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CEFUROXIME AXETIL TABLETS safely and effectively. See full prescribing information for CEFUROXIME AXETIL TABLETS. CEFUROXIME AXETIL tablets, for oral use Initial U.S. Approval: 1987
50090-2159-02023-01-30C16284748780-1f386c649-b15d-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CEFUROXIME AXETIL TABLETS safely and effectively. See full prescribing information for CEFUROXIME AXETIL TABLETS. CEFUROXIME AXETIL tablets, for oral use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2159-0Cefuroxime axetil20 in 1 BOTTLETABLET, FILM COATED2017
50090-2159-1Cefuroxime axetil14 in 1 BOTTLETABLET, FILM COATED1417

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2159CEFUROXIME AXETIL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]17Current NDC, Legacy NDC, 2 package rows20240912_84593261-838c-433a-8d9d-1d37b11058da.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2159-0EA - Each50090-2159f4d63fcb-70fb-436f-a5a9-c617e939008f12019-02-13
50090-2159-1EA - Each50090-2159e40d5dc7-98e2-4654-831e-294d6ad2171a12024-10-04

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 135 of 169 · 3,375 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
B HPAPIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (PRATENSIS), PYROGENIUM, RHUS TOX, SILICEAEnergique, Inc.04dfad30-9496-43c6-8ce8-ab04fdb9ce3b2024-05-06WarningsExact identifier
unii: ETJ7Z6XBU4
Neurotransmitter ProAETHUSA CYNAPIUM, GINKGO BILOBA, KALI PHOSPHORICUM, CEREBRUM SUIS, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALUMINA, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, CORTISONE ACETICUM, LEVOTHYROXINUM, LYCOPODIUM CLAVATUM, NADIDUM, PHOSPHORUS, UBIDECARENONUM, ZINCUM METALLICUM, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, GABA (GAMMA-AMINOBUTYRIC ACID), HISTAMINUM HYDROCHLORICUM, MELATONIN, NOREPINEPHRINE (BITARTRATE), OXYTOCIN, SEROTONIN (HYDROCHLORIDE)Energique, Inc.a80e5e2d-4c53-4b18-b89b-a7790073b7ed2024-05-06WarningsExact identifier
unii: LMI26O6933
Neurotransmitter ProAETHUSA CYNAPIUM, GINKGO BILOBA, KALI PHOSPHORICUM, CEREBRUM SUIS, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALUMINA, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, CORTISONE ACETICUM, LEVOTHYROXINUM, LYCOPODIUM CLAVATUM, NADIDUM, PHOSPHORUS, UBIDECARENONUM, ZINCUM METALLICUM, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, GABA (GAMMA-AMINOBUTYRIC ACID), HISTAMINUM HYDROCHLORICUM, MELATONIN, NOREPINEPHRINE (BITARTRATE), SEROTONIN (HYDROCHLORIDE), OXYTOCINEnergique, Inc.b433c635-e38b-4b3a-89cb-4a72a386ad842024-05-06WarningsExact identifier
unii: LMI26O6933
Tums Chewy Bites PeppermintCALCIUM CARBONATEHaleon US Holdings LLC45a44b2b-1633-49c5-8c55-9e9af3545c922024-05-03WarningsExact identifier
unii: H0G9379FGK
EnviroclenzBERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.92816bbe-96d6-45fc-9929-d3e6df394a332024-05-02WarningsExact identifier
unii: 6DC9Q167V3
unii: 368GB5141J
AI MiasmASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, SCROPHULARIA NODOSA, THYROIDINUM (SUIS), FORMICUM ACIDUM, PHOSPHORUS, SILICEA, SULPHUR, THUJA OCCIDENTALIS, AURUM METALLICUMEnergique, Inc.df829e4a-c982-4d02-b318-38b1fbc5072d2024-05-02WarningsExact identifier
unii: ETJ7Z6XBU4
Equqline Extra Strength Antacid Assorted FruitCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFI270c35f6-8ce2-4e88-940b-a02a749817582024-05-01WarningsExact identifier
unii: H0G9379FGK
Equaline Extra Strength Assorted Berry AntacidCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFI61d2e663-f0cf-4c14-a4f0-09897c760b132024-05-01WarningsExact identifier
unii: H0G9379FGK
Guardian Extra Strength Smooth Alkum Antacid 173bfCALCIUM CARBONATEGuardian Drug Companyae324739-8497-47aa-9e68-cbe42dfd83012024-05-01WarningsExact identifier
unii: H0G9379FGK
Cefuroxime AxetilCEFUROXIME AXETILNorthStar Rx LLCfd79c41e-b0e9-47dc-a3ce-caacdc66bc962024-04-30Warnings, Adverse reactionsExact identifier
rxcui: 309098
rxcui: 309097
unii: Z49QDT0J8Z
EQUALINE Regular Strength Antacid PeppermintCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFIea361a6e-70b6-42b9-b64c-05d5d038cf6a2024-04-30WarningsExact identifier
unii: H0G9379FGK
Guardian Ultra Strength Antacid Assorted FruitCALCIUM CARBONATEGuardian Drug Company0579de6c-8c25-4b7c-9184-1f73537fc2312024-04-29WarningsExact identifier
unii: H0G9379FGK
Cefuroxime AxetilCEFUROXIME AXETILAurobindo Pharma Limitedfaef39e9-d793-4191-a728-310f6fab759d2024-04-29Warnings, Adverse reactionsExact identifier
rxcui: 309098
rxcui: 309097
unii: Z49QDT0J8Z
Cefuroxime AxetilCEFUROXIME AXETILRising Pharma Holdings, Inc.66f8d37f-aebc-4435-af80-dfd7b37700882024-04-29Warnings, Adverse reactionsExact identifier
rxcui: 309098
rxcui: 309097
unii: Z49QDT0J8Z
Equqline Regular Strength AntacidCALCIUM CARBONATEUNITED NATURAL FOODS, INC. DBA UNFIaae36cef-404b-4bb0-b107-58140c4ab8912024-04-28WarningsExact identifier
unii: H0G9379FGK
Natural Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESarati International, Inc.16ef922d-78d1-1e70-e063-6394a90a3bbf2024-04-25WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 AlabasterTITANIUM DIOXIDEChantecaille Beaute Ince1c562b8-76c0-4c6e-9276-900784c8639e2024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 WheatTITANIUM DIOXIDEChantecaille Beaute Inc89f19f7a-60e3-4080-a49a-a4eb3e6c27de2024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 AuraTITANIUM DIOXIDEChantecaille Beaute Incde441a6c-55e3-4b11-afb3-d7db3c6971f02024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 BlissTITANIUM DIOXIDEChantecaille Beaute Inc16d9e226-7694-922a-e063-6394a90aea852024-04-24WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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