Cefuroxime Axetil

Product NDC
52959-939
11-digit product format
529590939
Labeler code
52959
Product ID
52959-939_35941438-1b02-495d-9333-f10c681f67dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime Axetil
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA065308
Marketing category
ANDA
Marketing start
2006-03-29
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
52959-939-202019-11-13C16284748780-197449f38-d0b8-f6ea-e053-dbdaa90aa703Cefuroxime Axetil Tablets, USP
52959-939-302019-11-13C16284748780-197449f38-d0b8-f6ea-e053-dbdaa90aa703Cefuroxime Axetil Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-939-20Cefuroxime Axetil20 in 1 BOTTLETABLET202
52959-939-30Cefuroxime Axetil30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-939-20EA - Each52959-939b80cdba9-654a-4329-bbc9-87ceb9ad399d12012-07-24
52959-939-30EA - Each52959-9394444664a-dee2-45b5-8c62-699fe8cff18512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFUROXIME AXETILACTIVE INGREDIENTZ49QDT0J8ZCEFUROXIME AXETIL TABLET [H.J. HARKINS COMPANY, INC.]2
CEFUROXIMEACTIVE MOIETYO1R9FJ93EDCEFUROXIME AXETIL TABLET [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-939CEFUROXIME AXETIL TABLET [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 2 package rows20111230_9ccf0781-4fb3-496e-bd58-54381ea33510.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309098cefuroxime axetil 500 MG Oral TabletPSN9ccf0781-4fb3-496e-bd58-54381ea335102
309098cefuroxime 500 MG Oral TabletSCD9ccf0781-4fb3-496e-bd58-54381ea335102
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSY9ccf0781-4fb3-496e-bd58-54381ea335102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-939-205295909392020 in 1 BOTTLEHistorical
52959-939-305295909393030 in 1 BOTTLEHistorical