FDA.reportPublic FDA data

Cefuroxime axetil

Product NDC
50090-2157
11-digit product format
500902157
Labeler code
50090
Product ID
50090-2157_4c85dedc-e76f-40fb-bad7-99d7a2146679
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime axetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065496
Marketing category
ANDA
Marketing start
2010-12-01
Substance
CEFUROXIME AXETIL
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cefuroxime axetil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFUROXIME AXETIL500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZ49QDT0J8Z
Rxcui309097, 309098

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba66f2a7-7ba5-e81a-8863-a38bd5c2e969Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2157-02023-02-07C16284748780-1f386c649-b471-0266-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
50090-2157-02023-01-30C16284748780-1f386c649-b471-0266-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
50090-2157-0Cefuroxime axetil20 in 1 BOTTLETABLET, FILM COATED2027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2157-0EA - Each50090-21577dadcb66-bc4f-4b46-9708-8fe5367bb0c812019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2157CEFUROXIME AXETIL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]27Current NDC, Legacy NDC, 1 package rows20240215_c89e8f4d-96c0-44c6-906a-b803141920b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309097cefuroxime axetil 250 MG Oral TabletPSNc89e8f4d-96c0-44c6-906a-b803141920b127
309098cefuroxime axetil 500 MG Oral TabletPSNc89e8f4d-96c0-44c6-906a-b803141920b127
309097cefuroxime 250 MG Oral TabletSCDc89e8f4d-96c0-44c6-906a-b803141920b127
309098cefuroxime 500 MG Oral TabletSCDc89e8f4d-96c0-44c6-906a-b803141920b127
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSYc89e8f4d-96c0-44c6-906a-b803141920b127
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSYc89e8f4d-96c0-44c6-906a-b803141920b127

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2157-05009021570020 TABLET, FILM COATED in 1 BOTTLE (50090-2157-0) 2015-10-210000-00-00NoNoCurrent