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 86 of 172 · 3,433 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cefuroxime axetilCEFUROXIME AXETILPD-Rx Pharmaceuticals, Inc.2af8f061-c0e1-3a1c-e054-00144ff8d46c2025-10-15Warnings, Adverse reactionsExact identifier
application number: ANDA065496
rxcui: 309097
unii: Z49QDT0J8Z
Cefuroxime axetilCEFUROXIME AXETILPD-Rx Pharmaceuticals, Inc.2af94304-8118-41c7-e054-00144ff8d46c2025-10-15Warnings, Adverse reactionsExact identifier
application number: ANDA065496
rxcui: 309097
unii: Z49QDT0J8Z
acid reducer completeFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDESafeway4f0a178c-d0ed-4bbc-a8ce-fda3789d25f02025-10-14WarningsExact identifier
unii: H0G9379FGK
DENTI BUONGIORNO PEACH MINT WHITENING TOOTHHYDROGEN PEROXIDE, SILICAATOSAFE CO., Ltd41196c2f-8e2e-a54d-e063-6294a90ad8a72025-10-14WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PEACH MINT WHITENING TOOTHHYDROGEN PEROXIDE, SILICADONG IL PHARMS CO.,LTD41198822-7c8f-ceb2-e063-6394a90a43732025-10-14WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO ORIGINAL TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD41197bb6-f6f4-c86d-e063-6294a90ad4762025-10-14WarningsExact identifier
unii: ETJ7Z6XBU4
CardinalExtra Strength Antacid Wintergreen flavorCALCIUM CARBONATECARDINAL HEALTH4e40989f-c710-442a-bb8d-02e813ddf04d2025-10-14WarningsExact identifier
unii: H0G9379FGK
Regular Strength Antacid Assorted FruitCALCIUM CARBONATECARDINAL HEALTHdef9eaef-308f-49f2-898b-469c2c395d272025-10-14WarningsExact identifier
unii: H0G9379FGK
Leader Extra Strength Sugar Free AntacidANTACIDCardinal Healthd7a6f1b8-bdf7-45bb-bab0-b22f45e784402025-10-14WarningsExact identifier
unii: H0G9379FGK
Cardinal Extra Strength Smooth Antacid Assorted FruitsCALCIUM CARBONATECARDINAL HEALTH84bf7fea-a071-4583-9453-1aea4d198ca62025-10-14WarningsExact identifier
unii: H0G9379FGK
ANTACID Extra StrengthCALCIUM CARBONATECardinal Health 110, LLC.3ce9b97b-1680-4299-9a2c-132318adbc0c2025-10-14WarningsExact identifier
unii: H0G9379FGK
ANTACID Extra StrengthCALCIUM CARBONATECARDINAL HEALTH 110, LLC.7c1b2ee6-b691-4c12-bed5-f0a360ad46bb2025-10-14WarningsExact identifier
unii: H0G9379FGK
ANTACID Ultra StrengthCALCIUM CARBONATECARDINAL HEALTH 110, LLC.d267ca31-09bd-46d3-be08-a259642f1b7f2025-10-14WarningsExact identifier
unii: H0G9379FGK
Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE , ZINC OXIDESkinlycious Pte Ltde0ad02c3-f5ed-4b72-ba96-07d9c489a4ea2025-10-13WarningsExact identifier
unii: 15FIX9V2JP
DENTI BUONGIORNO ORIGINAL TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEATOSAFE CO., Ltd4114ab09-1115-6b0b-e063-6394a90ab4422025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PLAQUE CARE TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEATOSAFE CO., Ltd41155922-d7ac-0a7a-e063-6294a90afe482025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PLAQUE CARE TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEDONG IL PHARMS CO.,LTD41157552-2473-176b-e063-6294a90a9ad02025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEATOSAFE CO., Ltd4115d122-3090-d3e5-e063-6294a90aafb62025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEDONG IL PHARMS CO.,LTD4115b653-63ff-703f-e063-6294a90a652a2025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
Vertra S Dorian Kona Gold Signature Face Stick SPF 38TITANIUM DIOXIDEEai-jr 286, Incb6c316c3-661b-6428-e053-2a95a90a1a6b2025-10-10WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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