FDA.reportPublic FDA data

Cefuroxime axetil

Product NDC
60687-283
11-digit product format
606870283
Labeler code
60687
Product ID
60687-283_3bb8ed50-e786-f167-e063-6294a90a6031
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime axetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA065496
Marketing category
ANDA
Marketing start
2023-06-26
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
Rxcui309097, 309098

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
60687-283-11Cefuroxime axetil1 in 1 BLISTER PACKTABLET, FILM COATED19
60687-283-94Cefuroxime axetil20 in 1 CARTONTABLET, FILM COATED209

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-283-11EA - Each60687-2838bb29cf1-0f2f-4d08-a9d4-0b5e875b2a0912023-04-07
60687-283-94EA - Each60687-2839e3470ca-f224-42cd-887c-997e004dc84112023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-283CEFUROXIME AXETIL TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]8Current NDC, 2 package rows20240726_f38418a7-dd90-4f20-b747-7ac086c53015.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309097cefuroxime axetil 250 MG Oral TabletPSNf38418a7-dd90-4f20-b747-7ac086c530159
309098cefuroxime axetil 500 MG Oral TabletPSNf38418a7-dd90-4f20-b747-7ac086c530159
309097cefuroxime 250 MG Oral TabletSCDf38418a7-dd90-4f20-b747-7ac086c530159
309098cefuroxime 500 MG Oral TabletSCDf38418a7-dd90-4f20-b747-7ac086c530159
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSYf38418a7-dd90-4f20-b747-7ac086c530159
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSYf38418a7-dd90-4f20-b747-7ac086c530159

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-283-11606870283111 in 1 BLISTER PACKHistorical
60687-283-946068702839420 BLISTER PACK in 1 CARTON (60687-283-94) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-283-11) 20 blister pack2023-06-26NoNoCurrent