Cefuroxime axetil

Product NDC
51407-334
11-digit product format
514070334
Labeler code
51407
Product ID
51407-334_502429f5-1f55-2030-e063-6394a90aef14
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime axetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA065496
Marketing category
ANDA
Marketing start
2010-06-07
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
Rxcui309097, 309098

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba66f2a7-7ba5-e81a-8863-a38bd5c2e969Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-334-20Cefuroxime axetil20 in 1 BOTTLETABLET, FILM COATED207
51407-334-60Cefuroxime axetil60 in 1 BOTTLETABLET, FILM COATED607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-334CEFUROXIME AXETIL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]6Current NDC, Legacy NDC, 2 package rows20240504_bb7955fe-5111-1662-e053-2a95a90a85a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309097cefuroxime axetil 250 MG Oral TabletPSNbb7955fe-5111-1662-e053-2a95a90a85a17
309098cefuroxime axetil 500 MG Oral TabletPSNbb7955fe-5111-1662-e053-2a95a90a85a17
309097cefuroxime 250 MG Oral TabletSCDbb7955fe-5111-1662-e053-2a95a90a85a17
309098cefuroxime 500 MG Oral TabletSCDbb7955fe-5111-1662-e053-2a95a90a85a17
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSYbb7955fe-5111-1662-e053-2a95a90a85a17
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSYbb7955fe-5111-1662-e053-2a95a90a85a17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51407-334-205140703342020 TABLET, FILM COATED in 1 BOTTLE (51407-334-20) 2021-01-290000-00-00NoNoCurrent
51407-334-605140703346060 TABLET, FILM COATED in 1 BOTTLE (51407-334-60) 2021-01-290000-00-00NoNoCurrent