Cefuroxime Axetil

Product NDC
50090-0782
11-digit product format
500900782
Labeler code
50090
Product ID
50090-0782_20df5b5d-15b3-4fdb-9adc-e96174e43a3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime Axetil
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065308
Marketing category
ANDA
Marketing start
2006-03-29
Substance
CEFUROXIME AXETIL
Active strength
250 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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0782-0Cefuroxime Axetil20 in 1 BOTTLETABLET206
50090-0782-1Cefuroxime Axetil14 in 1 BOTTLETABLET146

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0782-1EA - Each50090-0782ec82a3e6-e553-4aed-b425-3b575d4e49e712026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309097cefuroxime axetil 250 MG Oral TabletPSNa940ba01-2b53-4947-9019-d3d8f4e9ad806
309097cefuroxime 250 MG Oral TabletSCDa940ba01-2b53-4947-9019-d3d8f4e9ad806
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSYa940ba01-2b53-4947-9019-d3d8f4e9ad806

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-0782-05009007820020 TABLET in 1 BOTTLE (50090-0782-0) 20 tablet2014-11-28NoNoHistorical
50090-0782-15009007820114 TABLET in 1 BOTTLE (50090-0782-1) 14 tablet2026-01-19NoNoHistorical