FDA.reportPublic FDA data

Cefuroxime axetil

Product NDC
53002-2670
11-digit product format
530022670
Labeler code
53002
Product ID
53002-2670_3cb043cb-8cea-4b0c-bdc9-75e28c8dcc40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime axetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA065496
Marketing category
ANDA
Marketing start
2010-12-01
Marketing end
0000-00-00
Substance
CEFUROXIME AXETIL
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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
53002-2670-22025-01-30C16284748780-1f386c649-dff1-0266-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
53002-2670-22023-06-07C16284748780-1f386c649-dff1-0266-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
53002-2670-22023-01-30C16284748780-1f386c649-dff1-0266-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
53002-2670-2Cefuroxime axetil20 in 1 BOTTLETABLET, FILM COATED203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2670CEFUROXIME AXETIL TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 1 package rows20230609_418179e9-a533-4657-ae5a-848d1d187d76.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309098cefuroxime axetil 500 MG Oral TabletPSN418179e9-a533-4657-ae5a-848d1d187d763
309098cefuroxime 500 MG Oral TabletSCD418179e9-a533-4657-ae5a-848d1d187d763
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSY418179e9-a533-4657-ae5a-848d1d187d763

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-2670-25300226700220 TABLET, FILM COATED in 1 BOTTLE (53002-2670-2) 2019-01-010000-00-00NoNoCurrent