FDA.reportPublic FDA data

NDC 50090-2159-00 - 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
50090-2159-00
Package NDCs from labels
50090-2159-0, 50090-2159-1, 50090-2159-00
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 126 of 169 · 3,375 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Silicea 30XSILICON DIOXIDETrue Botanica, LLC1d99c26a-3f95-c138-e063-6294a90a9d622024-10-28WarningsExact identifier
unii: ETJ7Z6XBU4
LymphastatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), LOBELIA INFLATA, LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, LUNG (SUIS), PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CAUSTICUM, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA, SULPHUR, PYROGENIUMEnergique, Inc.ed3e0362-a4d3-46fa-a045-17bf659b777c2024-10-28WarningsExact identifier
unii: ETJ7Z6XBU4
HypothalmuparARALIA QUINQUEFOLIA, GINKGO BILOBA, HYDROCOTYLE ASIATICA, CEREBRUM SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, PHOSPHORUS, SILICEAEnergique, Inc.8b01e718-83b7-4f93-8fea-d0e37c7561852024-10-28WarningsExact identifier
unii: ETJ7Z6XBU4
Banana Boat Kids Mineral Protection SPF50TITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLCdc7701b5-0c73-b4df-e053-2a95a90a0f1b2024-10-27WarningsExact identifier
unii: 15FIX9V2JP
Banana Boat Mineral Sensitive SPF 50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCdc7913d5-58f2-3077-e053-2a95a90a16272024-10-27WarningsExact identifier
unii: 15FIX9V2JP
Banana Boat Mineral Sensitive Face SPF50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCdc783438-b28f-b7f4-e053-2a95a90a3d652024-10-27WarningsExact identifier
unii: 15FIX9V2JP
Banana Boat Sport Mineral SPF 50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCdc79790f-e2bc-5414-e053-2a95a90a9e7a2024-10-27WarningsExact identifier
unii: 15FIX9V2JP
Premier Value Chewable Antacid Extra Strength Tropical FruitANTACID TABLETSChain Drug Consortium8999b9c1-05d0-496b-88f2-062908a4fadc2024-10-25WarningsExact identifier
unii: H0G9379FGK
Premier Value Chewable Antacid Extra Strength Assorted FruitANTACID TABLETSChain Drug Consortiumef8ab31b-d050-446a-bca9-4a94d4ba17522024-10-25WarningsExact identifier
unii: H0G9379FGK
TiZO Mineral Stick - Tinted SPF 45TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDfd6d0080-0bef-4e7e-8ca5-b859639efd0c2024-10-25WarningsExact identifier
unii: 15FIX9V2JP
TiZO Mineral Stick Non-Tinted SPF 45TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDe7044f18-992a-4f60-9a2b-f11ed06db09b2024-10-25WarningsExact identifier
unii: 15FIX9V2JP
CoTZ Lip BalmTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD479a7d82-a068-4c2e-b50b-555c40e13e372024-10-25WarningsExact identifier
unii: 15FIX9V2JP
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.e17a8c35-2d49-4c99-b154-ea673c14753e2024-10-25WarningsExact identifier
unii: 15FIX9V2JP
IPKN Moist and Firm Beauty Balm Light MediumTITANIUM DIOXIDEInel Cosmetics Co., Ltd.1af6184e-3dc4-4eb3-8d51-aca7244734512024-10-25WarningsExact identifier
unii: 15FIX9V2JP
IPKN Moist and Firm Beauty Balm LightTITANIUM DIOXIDEInel Cosmetics Co., Ltd.77d77838-aa13-4939-a1a0-50189fbb3fe02024-10-25WarningsExact identifier
unii: 15FIX9V2JP
Premier Value Extra Strength Freshmint FlavorCALCIUM CARBONATE ,MAGNESIUM HYDROXIDECHAIN DRUG CONSORTIUM, LLC1192ebeb-f6cc-45db-8f07-12d36eb55a5f2024-10-25WarningsExact identifier
unii: H0G9379FGK
Premier Value Maximum Strength Assorted FruitCALCIUM CARBONATE, SIMETHICONEPHARMACY VALUE ALLIANCE, LLCe25bf9ca-415b-4a3e-a502-59074308da542024-10-25WarningsExact identifier
unii: H0G9379FGK
PV Extra Strength AntacidCALCIUM CARBONATEPHARMACY VALUE ALLIANCE, LLC8c92de83-ed60-46c3-b289-4b45a1915e242024-10-25WarningsExact identifier
unii: H0G9379FGK
Premier Value Chewable Antacid Ultra Strength Assorted FruitANTACID TABLETSChain Drug Consortium26c742a7-5806-44e0-bef0-c70a9d77dd232024-10-25WarningsExact identifier
unii: H0G9379FGK
Premier Value Chewable Antacid Assorted FruitANTACID TABLETSChain Drug Consortium, LLC00a58373-77ab-4a46-9862-d179e17c731a2024-10-25WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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