FDA.reportPublic FDA data

Cefuroxime Axetil

Product NDC
50090-0781
11-digit product format
500900781
Labeler code
50090
Product ID
50090-0781_b58a0509-ff56-4e58-84c9-287e17742abe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime Axetil
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065308
Marketing category
ANDA
Marketing start
2006-03-29
Substance
CEFUROXIME AXETIL
Active strength
250 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 AXETIL250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZ49QDT0J8Z
Rxcui309097

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
50090-0781-02023-01-30C16284748780-1f386c64a-126c-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
50090-0781-02023-01-30C16284748780-1f386c64a-126c-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
50090-0781-0Cefuroxime Axetil20 in 1 BOTTLETABLET206
50090-0781-3Cefuroxime Axetil14 in 1 BOTTLETABLET146

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0781-0EA - Each50090-0781de31c168-1d29-4f81-aeca-b1f93628a68712025-12-16
50090-0781-3EA - Each50090-0781bf8fa0b1-9670-4513-9112-15f959ccee0112025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0781CEFUROXIME AXETIL TABLET [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 2 package rows20210616_119c4d09-2324-498f-9318-1f8db49ad4b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309097cefuroxime axetil 250 MG Oral TabletPSN119c4d09-2324-498f-9318-1f8db49ad4b66
309097cefuroxime 250 MG Oral TabletSCD119c4d09-2324-498f-9318-1f8db49ad4b66
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSY119c4d09-2324-498f-9318-1f8db49ad4b66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0781-05009007810020 TABLET in 1 BOTTLE (50090-0781-0) 20 tablet2014-11-280000-00-00NoNoCurrent
50090-0781-35009007810314 TABLET in 1 BOTTLE (50090-0781-3) 14 tablet2025-10-07NoNoCurrent