FDA.reportPublic FDA data

Cefuroxime axetil

Product NDC
43063-656
11-digit product format
430630656
Labeler code
43063
Product ID
43063-656_4139ec87-a6f3-686f-e063-6294a90aaff2
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
43063-656-14Cefuroxime axetil14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1424
43063-656-20Cefuroxime axetil20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-656-14EA - Each43063-656b49230ea-30b0-49f9-913b-b36cc5c485bd12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-656CEFUROXIME AXETIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]23Current NDC, Legacy NDC, 2 package rows20240709_2af8f061-c0e1-3a1c-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309097cefuroxime axetil 250 MG Oral TabletPSN2af8f061-c0e1-3a1c-e054-00144ff8d46c24
309097cefuroxime 250 MG Oral TabletSCD2af8f061-c0e1-3a1c-e054-00144ff8d46c24
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSY2af8f061-c0e1-3a1c-e054-00144ff8d46c24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-656-144306306561414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-656-14) 2024-07-08NoNoHistorical
43063-656-204306306562020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-656-20) 2016-02-050000-00-00NoNoCurrent