Cefuroxime axetil

Product NDC
72789-035
11-digit product format
727890035
Labeler code
72789
Product ID
72789-035_303d9134-594c-63c6-e063-6394a90a4edf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime axetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA065496
Marketing category
ANDA
Marketing start
2010-12-01
Substance
CEFUROXIME AXETIL
Active strength
500 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 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
72789-035-14Cefuroxime axetil14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1424
72789-035-20Cefuroxime axetil20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2024
72789-035-60Cefuroxime axetil60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6024

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-035CEFUROXIME AXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]24Current NDC, Legacy NDC, 3 package rows20250316_15cabe73-f39d-4798-a840-115fe94f8f96.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309098cefuroxime axetil 500 MG Oral TabletPSN15cabe73-f39d-4798-a840-115fe94f8f9624
309098cefuroxime 500 MG Oral TabletSCD15cabe73-f39d-4798-a840-115fe94f8f9624
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSY15cabe73-f39d-4798-a840-115fe94f8f9624

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-035-147278900351414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-035-14) 2023-05-15NoNoCurrent
72789-035-207278900352020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-035-20) 2019-12-180000-00-00NoNoCurrent
72789-035-607278900356060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-035-60) 2019-12-180000-00-00NoNoCurrent