FDA.reportPublic FDA data

Cefuroxime axetil

Product NDC
43063-657
11-digit product format
430630657
Labeler code
43063
Product ID
43063-657_4139efd1-921a-b349-e063-6394a90a0404
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
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
43063-657-20Cefuroxime axetil20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2022
43063-657-60Cefuroxime axetil60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-657-20EA - Each43063-657442d4759-785d-4fa5-af7e-d8e60bbdf40612016-03-04
43063-657-60EA - Each43063-657b985bac6-093d-4bdf-9211-4227f8b999fc12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-657CEFUROXIME AXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]21Current NDC, Legacy NDC, 2 package rows20241016_2af94304-8118-41c7-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309097cefuroxime axetil 250 MG Oral TabletPSN2af94304-8118-41c7-e054-00144ff8d46c22
309097cefuroxime 250 MG Oral TabletSCD2af94304-8118-41c7-e054-00144ff8d46c22
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSY2af94304-8118-41c7-e054-00144ff8d46c22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-657-204306306572020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-657-20) 2016-02-050000-00-00NoNoCurrent
43063-657-604306306576060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-657-60) 2019-12-180000-00-00NoNoCurrent