Cefuroxime Axetil

Product NDC
70934-088
11-digit product format
709340088
Labeler code
70934
Product ID
70934-088_b816218e-39fd-3c71-e053-2995a90a9306
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime Axetil
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA065308
Marketing category
ANDA
Marketing start
2018-03-20
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
2022-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-088-20Cefuroxime Axetil20 in 1 BOTTLE, PLASTICTABLET203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-088CEFUROXIME AXETIL TABLET [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]3Legacy NDC, 1 package rows20210112_697ee167-b015-7534-e053-2a91aa0ace3f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309098cefuroxime axetil 500 MG Oral TabletPSN697ee167-b015-7534-e053-2a91aa0ace3f3
309098cefuroxime 500 MG Oral TabletSCD697ee167-b015-7534-e053-2a91aa0ace3f3
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSY697ee167-b015-7534-e053-2a91aa0ace3f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-088-207093400882020 TABLET in 1 BOTTLE, PLASTIC (70934-088-20) 20 tablet2018-03-200000-00-00NoNoCurrent