FDA.reportPublic FDA data

NDC 63304-831 - 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
63304-831
Package NDCs from labels
63304-831-30, 63304-831-04, 63304-831-11, 63304-831-77
Manufacturer
Ranbaxy Pharmaceuticals Inc.
Effective date
2008-10-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CEFUROXIME AXETIL - Ranbaxy Pharmaceuticals Inc.Ranbaxy Pharmaceuticals Inc.2008-10-07HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-831-04CEFUROXIME AXETIL250 in 1 BOTTLETABLET2501
63304-831-11CEFUROXIME AXETIL10 in 1 BLISTER PACKTABLET101
63304-831-30CEFUROXIME AXETIL30 in 1 BOTTLETABLET301
63304-831-77CEFUROXIME AXETIL10 in 1 CARTONTABLET101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-831CEFUROXIME AXETIL TABLET [RANBAXY PHARMACEUTICALS INC.]14 package rows20081030_5b6288fa-49da-4f44-b779-86e8404921db.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cefuroxime axetilACTIVE INGREDIENTZ49QDT0J8ZCEFUROXIME AXETIL TABLET [RANBAXY PHARMACEUTICALS INC.]1
CefuroximeACTIVE MOIETYO1R9FJ93EDCEFUROXIME AXETIL TABLET [RANBAXY PHARMACEUTICALS INC.]1
Colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CEFUROXIME AXETIL TABLET [RANBAXY PHARMACEUTICALS INC.]1
Croscarmellose sodiumINACTIVE INGREDIENTCEFUROXIME AXETIL TABLET [RANBAXY PHARMACEUTICALS INC.]1
FD&C Blue no. 1 aluminum lakeINACTIVE INGREDIENTCEFUROXIME AXETIL TABLET [RANBAXY PHARMACEUTICALS INC.]1
Microcrystalline celluloseINACTIVE INGREDIENTOP1R32D61UCEFUROXIME AXETIL TABLET [RANBAXY PHARMACEUTICALS INC.]1
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JCEFUROXIME AXETIL TABLET [RANBAXY PHARMACEUTICALS INC.]1
Stearic acidINACTIVE INGREDIENT4ELV7Z65APCEFUROXIME AXETIL TABLET [RANBAXY PHARMACEUTICALS INC.]1

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 2 of 2 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cefuroxime AxetilCEFUROXIME AXETILCoupler LLC2c619a79-6b69-b9fa-e063-6394a90a8f272025-01-23Warnings, Adverse reactionsExact identifier
rxcui: 309097
Cefuroxime AxetilCEFUROXIME AXETILCoupler LLC2c3a502f-8e72-c4d2-e063-6394a90a6fa52025-01-21Warnings, Adverse reactionsExact identifier
rxcui: 309098
Cefuroxime axetilCEFUROXIME AXETILA-S Medication Solutions84593261-838c-433a-8d9d-1d37b11058da2024-09-11Warnings, Adverse reactionsExact identifier
rxcui: 309097
Cefuroxime axetilCEFUROXIME AXETILNuCare Pharmaceuticals,Inc.83476d51-be74-748b-e053-2a91aa0a3d362024-07-15Warnings, Adverse reactionsExact identifier
rxcui: 309098
Cefuroxime axetilCEFUROXIME AXETILNuCare Pharmaceuticals,Inc.8c3c1c85-cbce-66e2-e053-2a95a90a94fe2024-06-18Warnings, Adverse reactionsExact identifier
rxcui: 309097
Cefuroxime AxetilCEFUROXIME AXETILNorthStar Rx LLCfd79c41e-b0e9-47dc-a3ce-caacdc66bc962024-04-30Warnings, Adverse reactionsExact identifier
rxcui: 309098
rxcui: 309097
Cefuroxime AxetilCEFUROXIME AXETILAurobindo Pharma Limitedfaef39e9-d793-4191-a728-310f6fab759d2024-04-29Warnings, Adverse reactionsExact identifier
rxcui: 309098
rxcui: 309095
rxcui: 309097
Cefuroxime AxetilCEFUROXIME AXETILRising Pharma Holdings, Inc.66f8d37f-aebc-4435-af80-dfd7b37700882024-04-29Warnings, Adverse reactionsExact identifier
rxcui: 309098
rxcui: 309097
Cefuroxime AxetilCEFUROXIME AXETILA-S Medication Solutionseb180b38-f8c8-4dbf-856a-347d3ebac8572024-02-27Warnings, Adverse reactionsExact identifier
rxcui: 309097
Cefuroxime axetilCEFUROXIME AXETILA-S Medication Solutionsc89e8f4d-96c0-44c6-906a-b803141920b12024-02-13Warnings, Adverse reactionsExact identifier
rxcui: 309098
rxcui: 309097
Cefuroxime AxetilCEFUROXIME AXETILA-S Medication Solutionsbcf7870a-7e45-4ae1-a9b4-457e4781886a2024-01-04Warnings, Adverse reactionsExact identifier
rxcui: 309097
Cefuroxime axetilCEFUROXIME AXETILProficient Rx LPe9a020ec-e446-469a-b1d1-07e82eefa3052023-07-01Warnings, Adverse reactionsExact identifier
rxcui: 309097
C47A836B-1A62-5086-72C6-6306CA1F35845b6288fa-49da-4f44-b779-86e8404921db2008-10-07Warnings, Adverse reactionsExact identifier
spl id: C47A836B-1A62-5086-72C6-6306CA1F3584
spl set id: 5b6288fa-49da-4f44-b779-86e8404921db

Reported adverse events (FAERS/openFDA)#

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