FDA.reportPublic FDA data

Cefuroxime Axetil

Product NDC
68071-3899
11-digit product format
680713899
Labeler code
68071
Product ID
68071-3899_3f92c452-18b5-5af8-e063-6394a90aaa53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime Axetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA065308
Marketing category
ANDA
Marketing start
2006-03-29
Substance
CEFUROXIME AXETIL
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cefuroxime Axetil
Listing expiration
2026-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3899-4Cefuroxime Axetil14 in 1 BOTTLETABLET, FILM COATED141

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309098cefuroxime axetil 500 MG Oral TabletPSN3f92c452-18b4-5af8-e063-6394a90aaa531
309098cefuroxime 500 MG Oral TabletSCD3f92c452-18b4-5af8-e063-6394a90aaa531
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSY3f92c452-18b4-5af8-e063-6394a90aaa531

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3899-46807138990414 TABLET, FILM COATED in 1 BOTTLE (68071-3899-4) 2025-09-24NoNoHistorical