Cefuroxime Axetil

Product NDC
66116-479
11-digit product format
661160479
Labeler code
66116
Product ID
66116-479_16a686e6-63f4-478f-a673-02dde9474eda
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime Axetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
MedVantx, Inc.
Application
ANDA065359
Marketing category
ANDA
Marketing start
2009-06-18
Marketing end
0000-00-00
Substance
CEFUROXIME AXETIL
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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
66116-479-202019-11-13C16284748780-197449f38-ca70-f6ea-e053-dbdaa90aa703CEFUROXIME AXETIL TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66116-479-20Cefuroxime Axetil20 in 1 BOTTLE, PLASTICTABLET, FILM COATED201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66116-479CEFUROXIME AXETIL TABLET, FILM COATED [MEDVANTX, INC.]1Legacy NDC, 1 package rows20120424_16a686e6-63f4-478f-a673-02dde9474eda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309098cefuroxime axetil 500 MG Oral TabletPSN16a686e6-63f4-478f-a673-02dde9474eda1
309098cefuroxime 500 MG Oral TabletSCD16a686e6-63f4-478f-a673-02dde9474eda1
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSY16a686e6-63f4-478f-a673-02dde9474eda1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66116-479-206611604792020 in 1 BOTTLE, PLASTICHistorical