FDA.reportPublic FDA data

Cefuroxime Axetil

Product NDC
16714-401
11-digit product format
167140401
Labeler code
16714
Product ID
16714-401_c89c84c5-710f-4a4a-8171-c38bee355c1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime Axetil
Dosage form
TABLET
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA065308
Marketing category
ANDA
Marketing start
2006-03-29
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
16714-401-01Cefuroxime Axetil20 in 1 BOTTLETABLET2012
16714-401-02Cefuroxime Axetil60 in 1 BOTTLETABLET6012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-401-01EA - Each16714-4014bf904f1-1394-45ea-aafc-07e13c081b6312014-09-03
16714-401-02EA - Each16714-401804d39da-237d-4a04-b2ed-f5f85775feee12014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFUROXIME AXETILACTIVE INGREDIENTZ49QDT0J8ZCEFUROXIME AXETIL TABLET [NORTHSTAR RX LLC]5
CEFUROXIMEACTIVE MOIETYO1R9FJ93EDCEFUROXIME AXETIL TABLET [NORTHSTAR RX LLC]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEFUROXIME AXETIL TABLET [NORTHSTAR RX LLC]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CEFUROXIME AXETIL TABLET [NORTHSTAR RX LLC]5
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EACEFUROXIME AXETIL TABLET [NORTHSTAR RX LLC]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCEFUROXIME AXETIL TABLET [NORTHSTAR RX LLC]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCEFUROXIME AXETIL TABLET [NORTHSTAR RX LLC]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFUROXIME AXETIL TABLET [NORTHSTAR RX LLC]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEFUROXIME AXETIL TABLET [NORTHSTAR RX LLC]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFUROXIME AXETIL TABLET [NORTHSTAR RX LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-401CEFUROXIME AXETIL TABLET [NORTHSTAR RX LLC]12Current NDC, Legacy NDC, 2 package rows20240501_fd79c41e-b0e9-47dc-a3ce-caacdc66bc96.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309097cefuroxime axetil 250 MG Oral TabletPSNfd79c41e-b0e9-47dc-a3ce-caacdc66bc9612
309098cefuroxime axetil 500 MG Oral TabletPSNfd79c41e-b0e9-47dc-a3ce-caacdc66bc9612
309097cefuroxime 250 MG Oral TabletSCDfd79c41e-b0e9-47dc-a3ce-caacdc66bc9612
309098cefuroxime 500 MG Oral TabletSCDfd79c41e-b0e9-47dc-a3ce-caacdc66bc9612
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSYfd79c41e-b0e9-47dc-a3ce-caacdc66bc9612
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSYfd79c41e-b0e9-47dc-a3ce-caacdc66bc9612
309098cefuroxime axetil 500 MG Oral TabletPSN697ee167-b015-7534-e053-2a91aa0ace3f3
309098cefuroxime 500 MG Oral TabletSCD697ee167-b015-7534-e053-2a91aa0ace3f3
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSY697ee167-b015-7534-e053-2a91aa0ace3f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-401-011671404010120 TABLET in 1 BOTTLE (16714-401-01) 20 tablet2006-03-290000-00-00NoNoCurrent
16714-401-021671404010260 TABLET in 1 BOTTLE (16714-401-02) 60 tablet2006-03-290000-00-00NoNoCurrent