Cefuroxime Axetil

Product NDC
50090-7668
11-digit product format
500907668
Labeler code
50090
Product ID
50090-7668_7c362b03-46b4-4307-8241-7ea18d4e05a5
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7668-0Cefuroxime Axetil20 in 1 BOTTLETABLET204
50090-7668-1Cefuroxime Axetil60 in 1 BOTTLETABLET604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7668-0EA - Each50090-7668949128f6-7754-486f-8922-d23f80007abf12025-12-16
50090-7668-1EA - Each50090-7668210bdc5d-1dcb-406b-833e-5a26785dbf3f12025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309098cefuroxime axetil 500 MG Oral TabletPSN85cdd8d9-557e-4d15-855a-027e7809cf644
309098cefuroxime 500 MG Oral TabletSCD85cdd8d9-557e-4d15-855a-027e7809cf644
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSY85cdd8d9-557e-4d15-855a-027e7809cf644

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7668-05009076680020 TABLET in 1 BOTTLE (50090-7668-0) 20 tablet2025-10-07NoNoCurrent
50090-7668-15009076680160 TABLET in 1 BOTTLE (50090-7668-1) 60 tablet2025-10-07NoNoCurrent