Cefuroxime Axetil

Product NDC
43063-623
11-digit product format
430630623
Labeler code
43063
Product ID
43063-623_4d524d1b-16d5-88ea-e063-6294a90a15a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime Axetil
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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
43063-623-14Cefuroxime Axetil14 in 1 BOTTLE, PLASTICTABLET1421
43063-623-20Cefuroxime Axetil20 in 1 BOTTLE, PLASTICTABLET2021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-623CEFUROXIME AXETIL TABLET [PD-RX PHARMACEUTICALS, INC.]19Current NDC, Legacy NDC, 2 package rows20241012_a84ac4ed-c268-4e9f-9df8-256e0a64cd16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309097cefuroxime axetil 250 MG Oral TabletPSNa84ac4ed-c268-4e9f-9df8-256e0a64cd1621
309097cefuroxime 250 MG Oral TabletSCDa84ac4ed-c268-4e9f-9df8-256e0a64cd1621
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSYa84ac4ed-c268-4e9f-9df8-256e0a64cd1621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-623-144306306231414 TABLET in 1 BOTTLE, PLASTIC (43063-623-14) 14 tablet2024-10-10NoNoCurrent
43063-623-204306306232020 TABLET in 1 BOTTLE, PLASTIC (43063-623-20) 20 tablet2015-10-270000-00-00NoNoCurrent
43063-623-304306306233030 TABLET in 1 BOTTLE, PLASTIC (43063-623-30) 30 tablet2015-10-270000-00-00NoNoCurrent