Cefuroxime Axetil

Product NDC
50090-7095
11-digit product format
500907095
Labeler code
50090
Product ID
50090-7095_89489a3f-de80-46af-b677-cc599a257e56
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7095-0Cefuroxime Axetil20 in 1 BOTTLETABLET201
50090-7095-3Cefuroxime Axetil14 in 1 BOTTLETABLET141

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7095-0EA - Each50090-70958f113515-c181-4a7a-b22e-ee3f74eb214112024-04-05
50090-7095-3EA - Each50090-7095b9042297-bace-477f-b70d-5e73fd6d7bf512024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7095CEFUROXIME AXETIL TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20240229_eb180b38-f8c8-4dbf-856a-347d3ebac857.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309097cefuroxime axetil 250 MG Oral TabletPSNeb180b38-f8c8-4dbf-856a-347d3ebac8571
309097cefuroxime 250 MG Oral TabletSCDeb180b38-f8c8-4dbf-856a-347d3ebac8571
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSYeb180b38-f8c8-4dbf-856a-347d3ebac8571

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7095-05009070950020 TABLET in 1 BOTTLE (50090-7095-0) 20 tablet2024-02-27NoNoCurrent
50090-7095-35009070950314 TABLET in 1 BOTTLE (50090-7095-3) 14 tablet2024-02-20NoNoCurrent