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 113 of 169 · 3,375 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Revlon Colorstay Liquid Makeup for Oily to Combination SkinZINC OXIDE, TITANIUM DIOXIDE MAKE-UPRevlon Consumer Products Corp410d1cb2-6c92-1ca3-e054-00144ff8d46c2024-12-31WarningsExact identifier
unii: 15FIX9V2JP
REVLON PHOTOREADY INSTA-FIX MAKEUPTITANIUM DIOXIDE, ZINC OXIDERevlon Consumer Products Corp442f2a06-47c0-2522-e054-00144ff88e882024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Revlon Youth FXZINC OXIDE, TITANIUM DIOXIDE MAKE-UPRevlon Consumer Products Corp442dec1e-032c-28de-e054-00144ff8d46c2024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Almay Smart Shade Skintone Matching Makeup MediumTITANIUM DIOXIDE ZINC OXIDEAlmay, Inc.2a971e38-af63-e069-e063-6294a90a8f772024-12-31WarningsExact identifier
unii: 15FIX9V2JP
REVLON AGE DEFYING FIRMING LIFTING MAKEUP SPF 15OCTINOXATE, TITANIUM DIOXIDE MAKE-UPRevlon Consumer Products Corpd9209277-469d-48f4-bf64-f39a70c195962024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Almay Smart Shade Skintone Matching Makeup LightTITANIUM DIOXIDE ZINC OXIDEAlmay, Inc.2a987b85-efdb-eb95-e063-6394a90aef812024-12-31WarningsExact identifier
unii: 15FIX9V2JP
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 LightTITANIUM DIOXIDE, ZINC OXIDEAlmay, Inc.2a984dd9-7293-77f0-e063-6294a90a8f1e2024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Rite Aid Hydration Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLRite Aid Corporationecac1351-e944-21da-e053-2995a90a6d342024-12-31WarningsExact identifier
unii: 6DC9Q167V3
Almay Healthy Biome MakeupHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEAlmayab20969a-8640-307d-e053-2a95a90a004d2024-12-30WarningsExact identifier
unii: 15FIX9V2JP
DUAL ACTION Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE TABLET, CHEWABLELil' Drug Store Products, Inc.f3cf2e19-1348-0eac-e053-2a95a90a46c12024-12-30WarningsExact identifier
unii: H0G9379FGK
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUSOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEExelencia importers Corp.2a845e4c-86e7-1799-e063-6294a90a9b2b2024-12-30WarningsExact identifier
unii: 15FIX9V2JP
SkinCeuticals Sheer Physical UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc2035ab03-80b4-49f4-b379-eb8bc42c9cee2024-12-30WarningsExact identifier
unii: 15FIX9V2JP
SkinCeuticals Physical Matte UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Incb137b3d0-212b-440a-b158-62ace4b4eff32024-12-30WarningsExact identifier
unii: 15FIX9V2JP
SkinCeuticals Physical UV Defense Broad Spectrum SPF 30 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc3a6db7d3-6c59-4633-a97e-1c03127246d32024-12-30WarningsExact identifier
unii: 15FIX9V2JP
Kiehls Since 1851 Activated Sun Protector For Face and Body Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc87496037-36ca-4c5f-973f-46626cf4096e2024-12-27WarningsExact identifier
unii: 15FIX9V2JP
RODAN and FIELDS UNBLEMISHTITANIUM DIOXIDE, ZINC OXIDEBentley Laboratories, LLC2b3b6b62-364f-4aba-8024-3a73752b4c562024-12-27WarningsExact identifier
unii: 15FIX9V2JP
NORWEX Protect Prevent Mineral Facial Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, CORPORATION0d489154-6168-977e-e063-6394a90aa6092024-12-26WarningsExact identifier
unii: 15FIX9V2JP
ANTACIDCALCIUM CARBONATEAdvance Pharmaceutical Inc.face4e8c-3d0f-4c2e-83c1-44397b225ae72024-12-26WarningsExact identifier
unii: H0G9379FGK
ANTACIDCALCIUM CARBONATEAdvance Pharmaceutical Inc.3203dfc5-2cb1-4703-8d81-63fba07ddd982024-12-26WarningsExact identifier
unii: H0G9379FGK
HEB Extra Strength Smooth Antacid Assorted FruitsCALCIUM CARBONATEH E B2faac316-7b59-4df8-b751-37069e8652632024-12-26WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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