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 79 of 172 · 3,433 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CERAVE DEVELOPED WITH DERMOTOLOGISTS Invisible Mineral Sunscreen FOR ALL SKIN TYPES AND TONES FACE UVB AND UVA BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc372894af-bed7-474f-95d4-69a8c3f215ef2025-11-14WarningsExact identifier
unii: 15FIX9V2JP
ALUMIZENGARLIC, AVENA SATIVA FLOWERING TOP, BERBERIS VULGARIS ROOT BARK, ARCTIUM LAPPA ROOT, PHYTOLACCA AMERICANA ROOT, SOLIDAGO VIRGAUREA FLOWERING TOP, ALUMINUM OXIDE, SILVER NITRATE, BARIUM CARBONATE, BERYLLIUM, CADMIUM, COPPER, HYDROFLUORIC ACID, INDIUM, IODINE, LITHIUM CARBONATE, MERCURIUS SOLUBILIS, NICKEL CARBONATE HYDROXIDE TETRAHYDRATE, NITROUS OXIDE, LEAD, SELENIUM, STRONTIUM CARBONATE, TITANIUM, ARSENIC TRIOXIDE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED.Natural Creations, Inc.4760ab09-1141-4944-b840-804ae6d86d2d2025-11-13WarningsExact identifier
unii: LMI26O6933
Glo SkinTITANIUM DIOXIDE, ZINC OXIDEGlo Skin Beautyf4bed574-68c1-0d2c-e053-2a95a90a15ff2025-11-13WarningsExact identifier
unii: 15FIX9V2JP
Anxiety HPARSENIC TRIOXIDE, CALCIUM CARBONATE, STRYCHNOS IGNATII SEED, POTASSIUM CARBONATE, LACHESIS MUTA VENOM, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLANatural Creations, Inc.13d92246-c20e-47a8-b88f-22da876fc5452025-11-13WarningsExact identifier
unii: H0G9379FGK
BELLA HPATROPA BELLADONNA, CONIUM MACULATUM FLOWERING TOP, SOLANUM DULCAMARA TOP, CALCIUM SULFIDE, POTASSIUM DICHROMATE, MERCURIUS SOLUBILIS, ANEMONE PULSATILLA, SILICON DIOXIDE, MATRICARIA RECUTITA.Natural Creations, Inc.8e46906b-9c22-4a8e-ae4e-f1fbfb3d35b12025-11-13WarningsExact identifier
unii: ETJ7Z6XBU4
BONE HPSODIUM BORATE, OYSTER SHELL CALCIUM CARBONATE CRUDE, CALCIUM FLUORIDE, TRIBASIC CALCIUM PHOSPHATE, EUPATORIUM PERFOLIATUM FLOWERING TOP, IRON, HYDROFLUORIC ACID, HEKLA LAVA, TOXICODENDRON PUBESCENS LEAF, RUTA GRAVEOLENS FLOWERING TOP, SILICON DIOXIDE, COMFREY ROOT.Natural Creations, Inc.93d2b385-9ce3-4d16-b428-1638e9a55f922025-11-13WarningsExact identifier
unii: ETJ7Z6XBU4
Essential Defense Mineral Shield Broad Spectrum SPF 32 Sunscreen TINTEDTITANIUM DIOXIDE AND ZINC OXIDEAllergan, Inc.279a5214-79b2-44e9-b003-378d0b9923952025-11-11WarningsExact identifier
unii: 15FIX9V2JP
Topcare Antacid Extra Strength Assorted BerryCALCIUM CARBONATETopco Associates LLC14f6f475-32d6-4783-8dcc-1fe265902d552025-11-10WarningsExact identifier
unii: H0G9379FGK
Topcare Antacid CalciumCALCIUM CARBONATETopco Associates LLC38c26f49-fb5e-480c-9164-bf5edcf0726b2025-11-10WarningsExact identifier
unii: H0G9379FGK
buttah Tinted Mineral Sunscreen SPF-30TITANIUM DIOXIDE, ZINC OXIDEButtah Enterprises, LLC.43458152-0775-dd9c-e063-6394a90a61402025-11-10WarningsExact identifier
unii: 15FIX9V2JP
LUMOe SKIN1 Skin RemedyKALI MURIATICUM, PRUNUS SPINOSA, SILICEA, SARSAPARILLAApplied Bioenergetics, LLCd4d7fd2f-66bf-407d-ad36-2462e880b9f52025-11-10WarningsExact identifier
unii: ETJ7Z6XBU4
Walgreens SPF 50 Tinted Mineral FluidTITANIUM DIOXIDEWalgreens345918e3-95f8-404c-e063-6394a90a3fca2025-11-09WarningsExact identifier
unii: 15FIX9V2JP
Topcare Antacid CalciumCALCIUM CARBONATETopco Associates LLC.bb99b942-1f84-43e1-a18d-3a975cddc59e2025-11-08WarningsExact identifier
unii: H0G9379FGK
Topcare Antacid Calcium Regular StrengthCALCIUM CARBONATETopco Associates LLC2606ac08-9760-4ff6-8d90-51fbb04e6ac82025-11-08WarningsExact identifier
unii: H0G9379FGK
Topcare Antacid Calcium Extra StrengthCALCIUM CARBONATETopco Associates LLC495d97b0-d95c-46d1-a76a-56ac7f8235382025-11-08WarningsExact identifier
unii: H0G9379FGK
Topcare Antacid Calcium Extra StrengthCALCIUM CARBONATETopco Associates LLC.73b4cda2-900a-4380-a0ae-0abfecdb72632025-11-08WarningsExact identifier
unii: H0G9379FGK
Topcare Extra Strength Antacid Assorted FruitCALCIUM CARBONATETopco Associates LLC2677ca2b-b211-475e-a9c4-643fd54a744f2025-11-08WarningsExact identifier
unii: H0G9379FGK
TopCare Antacid CalciumCALCIUM CARBONATETopco Associates LLCb94eac38-62d0-49a2-bb49-053fda8129e22025-11-08WarningsExact identifier
unii: H0G9379FGK
Topcare Antacid CalciumCALCIUM CARBONATETopco Associates LLC04b3d397-df99-44e2-a191-6e9199b083982025-11-08WarningsExact identifier
unii: H0G9379FGK
topcare Antacid Calcium Ultra StrengthCALCIUM CARBONATETopco Associates LLC6e2788b3-1e33-4908-aa2c-475d69b94ee62025-11-08WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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