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 83 of 172 · 3,433 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e l f Camo Semi Matte CC SPF 30 Tan 460 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.49255019-fa24-4667-b527-ef7189a51f122025-10-31WarningsExact identifier
unii: 15FIX9V2JP
Clove Hill Tinted Mineral Sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDEClove Hill LLCeb2ff5a7-384f-4379-b149-47c1c8c2291d2025-10-30WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEClove Hill LLCa37db64d-8b79-40f4-843f-f38949c5b9d22025-10-30WarningsExact identifier
unii: 15FIX9V2JP
MOOYAM Dark Skin SunscreenSUNSCREENGuangdong Bisutang Biotechnology Co., LTD4246e9f1-1c51-d888-e063-6394a90abda02025-10-29WarningsExact identifier
unii: 15FIX9V2JP
Regular Strength AntacidCALCIUM CARBONATESAFEWAYce44254f-6e33-4cbd-a609-6a926376efaf2025-10-29WarningsExact identifier
unii: H0G9379FGK
Extra StrengthCALCIUM CARBONATEBETTER LIVING BRANDS, LLC9b311b76-1892-4b74-a07a-8b321436d4a02025-10-29WarningsExact identifier
unii: H0G9379FGK
Extra StrengthANTACID TABLETSSAFEWAYf91aa7da-8bdc-4fd2-a9de-fef21674e5152025-10-29WarningsExact identifier
unii: H0G9379FGK
Extra Strength SmoothCALCIUM CARBONATESAFEWAY4314ac58-03aa-479c-a711-4818cc3325312025-10-29WarningsExact identifier
unii: H0G9379FGK
Extra StrengthANTACID TABLETSSAFEWAY5bdb868d-016d-4175-9283-86c5b77bb26e2025-10-29WarningsExact identifier
unii: H0G9379FGK
Extra StrengthANTACID TABLETSSAFEWAY03853f03-081d-4a78-b383-66ac9754d46f2025-10-29WarningsExact identifier
unii: H0G9379FGK
Ultra StrengthCALCIUM CARBONATEBETTER LIVING BRANDS LLC3ff92c9a-987f-468e-9e18-1e3e171ede142025-10-29WarningsExact identifier
unii: H0G9379FGK
Ultra StrengthCALCIUM CARBONATEBETTER LIVING BRANDS LLC35b3d9d0-b04d-4f6d-b99d-435233803d4b2025-10-29WarningsExact identifier
unii: H0G9379FGK
Ultra StrengthANTACID TABLETSSAFEWAY4c6cdd81-5145-4a1f-888f-85cf5d856c392025-10-29WarningsExact identifier
unii: H0G9379FGK
Extra Strength SmoothANTACID TABLETSSAFEWAY8ed35c3b-9878-4889-90f7-a3973cf806e02025-10-29WarningsExact identifier
unii: H0G9379FGK
non-tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEClove Hill LLC311b270f-b9e2-2374-e063-6294a90af5812025-10-29WarningsExact identifier
unii: 15FIX9V2JP
Publix Regular Strength Assorted FruitCALCIUM CARBONATEPUBLIX SUPER MARKETS, INCfd637431-7a08-4454-9cae-a68716d2d0fa2025-10-28WarningsExact identifier
unii: H0G9379FGK
Publix Regular Strength Peppermint FlavorCALCIUM CARBONATEPUBLIX SUPER MARKETS, INCc41b6cc2-c852-45fd-858c-c7bedc5dc8822025-10-28WarningsExact identifier
unii: H0G9379FGK
Publix Extra Strength Assorted BerryCALCIUM CARBONATEPUBLIX SUPER MARKETS, INCa270fc36-f2b2-4f56-81d4-cf165f6b5abe2025-10-28WarningsExact identifier
unii: H0G9379FGK
Extra Strength Sugar Free Orange Cream FlavorCALCIUM CARBONATEPUBLIX SUPER MARKETS, INC4dbdabc4-280d-4c9a-8c54-84afc615c8c72025-10-28WarningsExact identifier
unii: H0G9379FGK
Publix Extra Strength Tropical FruitCALCIUM CARBONATEPUBLIX SUPER MARKETS, INC28e8dd03-25cf-43db-8c4d-3aae99be9d532025-10-28WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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