FDA.reportPublic FDA data

Cefuroxime Axetil

Product NDC
68071-2879
11-digit product format
680712879
Labeler code
68071
Product ID
68071-2879_ee8f081f-f787-8f93-e053-2995a90ada0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime Axetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065308
Marketing category
ANDA
Marketing start
2006-03-29
Marketing end
0000-00-00
Substance
CEFUROXIME AXETIL
Active strength
250 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
68071-2879-22025-01-30C16284748780-12cef2736-8a27-d83d-e063-dadaa90ab31fThese 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
68071-2879-2Cefuroxime Axetil2 in 1 BOTTLETABLET, FILM COATED22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2879CEFUROXIME AXETIL TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 1 package rows20221206_edaff3b7-5bfe-83ef-e053-2a95a90ae42f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309097cefuroxime axetil 250 MG Oral TabletPSNedaff3b7-5bfe-83ef-e053-2a95a90ae42f2
309097cefuroxime 250 MG Oral TabletSCDedaff3b7-5bfe-83ef-e053-2a95a90ae42f2
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSYedaff3b7-5bfe-83ef-e053-2a95a90ae42f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2879-26807128790220 TABLET, FILM COATED in 1 BOTTLE (68071-2879-2) 2022-11-170000-00-00NoNoCurrent