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 74 of 172 · 3,433 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM Silicea Icing SugarSILICEA ICING SUGARBM Private Limited37c1f61d-dfe4-9dcf-e063-6394a90aceb12025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
BM Calcium carbonate (Calc Carb)CALCIUM CARBONATEBM Private Limited380279be-6186-146b-e063-6294a90a0d642025-12-02WarningsExact identifier
unii: H0G9379FGK
D-CALCALCIUM CARBONATEA&Z Pharmaceutical Inc.4c202dae-1ad8-44ab-a272-bdca808453022025-12-01WarningsExact identifier
unii: H0G9379FGK
Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDETHG Beauty USA LLC44952d01-7f38-0a9c-e063-6394a90a20182025-11-27WarningsExact identifier
unii: 15FIX9V2JP
Bambusa PulsatillaBAMBUSA PULSATILLAUriel Pharmacy Inc.0776c3be-088d-422c-9c12-08fcaae823e12025-11-26WarningsExact identifier
unii: ETJ7Z6XBU4
Splash Pure PFPROPYLENE GLYCOLLABORATORIOS SOPHIA, S.A. DE C.V.40ad7ae5-1f2a-e3b1-e063-6294a90a6f842025-11-26WarningsExact identifier
unii: 6DC9Q167V3
Antacid Regular StrengthANTACIDWALGREEN CO.ce5eef7f-497d-4c88-be6a-17eeb6e07f5b2025-11-25WarningsExact identifier
unii: H0G9379FGK
Antacid Extra StrengthANTACIDWALGREEN CO.2981c5f7-121a-4030-86b1-559061030e7a2025-11-25WarningsExact identifier
unii: H0G9379FGK
Antacid Extra StrengthANTACID CALCIUM CARBONATEWALGREEN CO.14baa410-6ce3-4ddb-aac7-e2172d1506c42025-11-25WarningsExact identifier
unii: H0G9379FGK
Antacid Extra StrengthANTACIDWALGREEN CO.aa797e94-6560-41c9-8c71-458a1086e8412025-11-25WarningsExact identifier
unii: H0G9379FGK
Extra Strength AntacidCALCIUM CARBONATEWALGREEN COMPANYd66ec376-9cac-4de5-aac8-7c6f9aa210ce2025-11-25WarningsExact identifier
unii: H0G9379FGK
Antacid Extra Strength WintergreenANTACIDWALGREEN CO.ae2cd8fb-73e2-43f4-8aa9-f92b06e21a6d2025-11-25WarningsExact identifier
unii: H0G9379FGK
Antacid Ultra StrengthANTACIDWALGREEN CO.09ef90c3-1fc3-48be-8071-2fa387a461752025-11-25WarningsExact identifier
unii: H0G9379FGK
Antacid Ultra Strength Assorted FruitsANTACIDWALGREEN CO.6d6cecdc-646b-4c7b-b325-9423c29c57fc2025-11-25WarningsExact identifier
unii: H0G9379FGK
Antacid Ultra Strength Assorted FruitsANTACIDWALGREEN CO.e1b55f3a-c6d7-4374-acc7-134786a3765e2025-11-25WarningsExact identifier
unii: H0G9379FGK
ULTRA STRENGTH AntacidCALCIUM CARBONATEWALGREEN COa4dcf7b9-d2c3-45d3-9410-fc4d55052a3c2025-11-25WarningsExact identifier
unii: H0G9379FGK
Prenate ChewableCALCIUM CARBONATE, CHOLECALCIFEROL, MAGNESIUM OXIDE, BORON, FOLIC ACID, LEVOMEFOLATE GLUCOSAMINE, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN AND BLUEBERRYAvion Pharmaceuticals, LLC917f02ce-51b9-4819-81e0-522842f6732a2025-11-25Adverse reactionsExact identifier
unii: H0G9379FGK
Thyroid-AdrenalADRENALINUM, THYROIDINUM, ALOE, CALC. CARB., CHELIDONIUM MAJUS, CONIUM, GRAPHITES, IODIUM, LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, PHYTOLACCA, RHUS TOXICODENDRON, SILICEA, SPONGIA, ECHINACEANewton Laboratories, Inc.b597504a-c667-225c-e053-2a95a90ac7042025-11-25WarningsExact identifier
unii: ETJ7Z6XBU4
DOCTRUST ONE S ToothSODIUM FLUORIDE, DENTAL TYPE SILICA, POTASSIUM NIRATEDONG IL PHARMS CO.,LTD4476923a-48f1-9f72-e063-6394a90a07082025-11-25WarningsExact identifier
unii: ETJ7Z6XBU4
DOCTRUST K ToothSILICON DIOXIDE, SODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD44768dd1-b132-c33b-e063-6294a90accd42025-11-25WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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