Cefuroxime axetil

Product NDC
52959-308
11-digit product format
529590308
Labeler code
52959
Product ID
52959-308_14405431-115c-417b-918e-17a63bb6042a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime axetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA065496
Marketing category
ANDA
Marketing start
2010-12-01
Marketing end
0000-00-00
Substance
CEFUROXIME AXETIL
Active strength
250 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
52959-308-202019-11-13C16284748780-197449f38-c623-f6ea-e053-dbdaa90aa7031bc56a86-735c-4787-826a-9bb59027fa09

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-308-20Cefuroxime axetil20 in 1 BOTTLETABLET, FILM COATED202

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cefuroxime axetilACTIVE INGREDIENTZ49QDT0J8ZCEFUROXIME AXETIL TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
CefuroximeACTIVE MOIETYO1R9FJ93EDCEFUROXIME AXETIL TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-308CEFUROXIME AXETIL TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 1 package rows20111223_1bc56a86-735c-4787-826a-9bb59027fa09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309097cefuroxime axetil 250 MG Oral TabletPSN1bc56a86-735c-4787-826a-9bb59027fa092
309097cefuroxime 250 MG Oral TabletSCD1bc56a86-735c-4787-826a-9bb59027fa092
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSY1bc56a86-735c-4787-826a-9bb59027fa092

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-308-205295903082020 in 1 BOTTLEHistorical