FDA.reportPublic FDA data

Cefuroxime axetil

Product NDC
68071-4947
11-digit product format
680714947
Labeler code
68071
Product ID
68071-4947_1b2e322e-13be-c58d-e063-6394a90a2829
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime axetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065496
Marketing category
ANDA
Marketing start
2010-12-01
Substance
CEFUROXIME AXETIL
Active strength
250 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 AXETIL250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZ49QDT0J8Z
Rxcui309097

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
68071-4947-22024-06-27C16284748780-1ba0f9c33-1d96-a910-e053-dadaa90a0b85These 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
68071-4947-22023-01-30C16284748780-1ba0f9c33-1d96-a910-e053-dadaa90a0b85These 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
68071-4947-22021-02-18C16284748780-1ba0f9c33-1d96-a910-e053-dadaa90a0b85These 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
68071-4947-22021-01-29C16284748780-1ba0f9c33-1d96-a910-e053-dadaa90a0b85These 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
68071-4947-2Cefuroxime axetil2 in 1 BOTTLETABLET, FILM COATED23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4947CEFUROXIME AXETIL TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240629_8c3c1c85-cbce-66e2-e053-2a95a90a94fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309097cefuroxime axetil 250 MG Oral TabletPSN8c3c1c85-cbce-66e2-e053-2a95a90a94fe3
309097cefuroxime 250 MG Oral TabletSCD8c3c1c85-cbce-66e2-e053-2a95a90a94fe3
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSY8c3c1c85-cbce-66e2-e053-2a95a90a94fe3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4947-2680714947022 TABLET, FILM COATED in 1 BOTTLE (68071-4947-2) 2019-06-260000-00-00NoNoCurrent