FDA.reportPublic FDA data

Cefuroxime Axetil

Product NDC
70518-3215
11-digit product format
705183215
Labeler code
70518
Product ID
70518-3215_4ab61a1a-01ab-1dfa-e063-6294a90a4d37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime Axetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA065308
Marketing category
ANDA
Marketing start
2021-09-08
Substance
CEFUROXIME AXETIL
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cefuroxime Axetil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFUROXIME AXETIL500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZ49QDT0J8Z
Rxcui309098

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
70518-3215-02023-02-28C16284748780-1f386c649-a126-0266-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
70518-3215-02023-01-30C16284748780-1f386c649-a126-0266-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
70518-3215-0Cefuroxime Axetil30 in 1 BLISTER PACKTABLET, FILM COATED309
70518-3215-1Cefuroxime Axetil20 in 1 BOTTLE, PLASTICTABLET, FILM COATED209
70518-3215-2Cefuroxime Axetil30 in 1 BOTTLE, PLASTICTABLET, FILM COATED309
70518-3215-3Cefuroxime Axetil20 in 1 BOTTLE, PLASTICTABLET, FILM COATED209
70518-3215-4Cefuroxime Axetil14 in 1 BOTTLE, PLASTICTABLET, FILM COATED149

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3215CEFUROXIME AXETIL TABLET, FILM COATED [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 5 package rows20250125_76cec54f-d167-4298-951b-5411a3c47f4a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309098cefuroxime axetil 500 MG Oral TabletPSN76cec54f-d167-4298-951b-5411a3c47f4a9
309098cefuroxime 500 MG Oral TabletSCD76cec54f-d167-4298-951b-5411a3c47f4a9
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSY76cec54f-d167-4298-951b-5411a3c47f4a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3215-07051832150030 TABLET, FILM COATED in 1 BLISTER PACK (70518-3215-0) 2021-09-080000-00-00NoNoCurrent
70518-3215-17051832150120 in 1 BOTTLE, PLASTICHistorical
70518-3215-27051832150230 in 1 BOTTLE, PLASTICHistorical
70518-3215-37051832150320 in 1 BOTTLE, PLASTICHistorical
70518-3215-47051832150414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3215-4) 2024-01-13NoNoHistorical