FDA.reportPublic FDA data

Cefuroxime Axetil

Product NDC
65862-700
11-digit product format
658620700
Labeler code
65862
Product ID
65862-700_5716a24a-653f-488a-bb44-85abffcbf92c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime Axetil
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
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
Rxcui309095, 309097, 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
65862-700-20Cefuroxime Axetil20 in 1 BOTTLETABLET2013
65862-700-60Cefuroxime Axetil60 in 1 BOTTLETABLET6013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-700-20EA - Each65862-700350db228-1439-49b2-b12f-5f12acf0cff812014-04-03
65862-700-60EA - Each65862-700faac026d-4e5a-4de0-abcd-911cca9644dd12014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFUROXIME AXETILACTIVE INGREDIENTZ49QDT0J8ZCEFUROXIME AXETIL TABLET [AUROBINDO PHARMA LIMITED]4
CEFUROXIMEACTIVE MOIETYO1R9FJ93EDCEFUROXIME AXETIL TABLET [AUROBINDO PHARMA LIMITED]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEFUROXIME AXETIL TABLET [AUROBINDO PHARMA LIMITED]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CEFUROXIME AXETIL TABLET [AUROBINDO PHARMA LIMITED]4
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EACEFUROXIME AXETIL TABLET [AUROBINDO PHARMA LIMITED]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCEFUROXIME AXETIL TABLET [AUROBINDO PHARMA LIMITED]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCEFUROXIME AXETIL TABLET [AUROBINDO PHARMA LIMITED]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFUROXIME AXETIL TABLET [AUROBINDO PHARMA LIMITED]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEFUROXIME AXETIL TABLET [AUROBINDO PHARMA LIMITED]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFUROXIME AXETIL TABLET [AUROBINDO PHARMA LIMITED]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-700CEFUROXIME AXETIL TABLET [AUROBINDO PHARMA LIMITED]13Current NDC, Legacy NDC, 2 package rows20240501_faef39e9-d793-4191-a728-310f6fab759d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309095cefuroxime axetil 125 MG Oral TabletPSNfaef39e9-d793-4191-a728-310f6fab759d13
309097cefuroxime axetil 250 MG Oral TabletPSNfaef39e9-d793-4191-a728-310f6fab759d13
309098cefuroxime axetil 500 MG Oral TabletPSNfaef39e9-d793-4191-a728-310f6fab759d13
309095cefuroxime 125 MG Oral TabletSCDfaef39e9-d793-4191-a728-310f6fab759d13
309097cefuroxime 250 MG Oral TabletSCDfaef39e9-d793-4191-a728-310f6fab759d13
309098cefuroxime 500 MG Oral TabletSCDfaef39e9-d793-4191-a728-310f6fab759d13
309095cefuroxime (as cefuroxime axetil) 125 MG Oral TabletSYfaef39e9-d793-4191-a728-310f6fab759d13
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSYfaef39e9-d793-4191-a728-310f6fab759d13
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSYfaef39e9-d793-4191-a728-310f6fab759d13
309098cefuroxime axetil 500 MG Oral TabletPSN85cdd8d9-557e-4d15-855a-027e7809cf644
309098cefuroxime axetil 500 MG Oral TabletPSNaa6685c1-51ed-466a-ae7f-89a82986a7b14
309098cefuroxime 500 MG Oral TabletSCD85cdd8d9-557e-4d15-855a-027e7809cf644
309098cefuroxime 500 MG Oral TabletSCDaa6685c1-51ed-466a-ae7f-89a82986a7b14
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSYaa6685c1-51ed-466a-ae7f-89a82986a7b14
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSY85cdd8d9-557e-4d15-855a-027e7809cf644
309098cefuroxime axetil 500 MG Oral TabletPSN0ab128e7-cfc4-65f1-e063-6394a90ad0f02
309098cefuroxime 500 MG Oral TabletSCD0ab128e7-cfc4-65f1-e063-6394a90ad0f02
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSY0ab128e7-cfc4-65f1-e063-6394a90ad0f02
309098cefuroxime axetil 500 MG Oral TabletPSN2c3a502f-8e72-c4d2-e063-6394a90a6fa51
309098cefuroxime 500 MG Oral TabletSCD2c3a502f-8e72-c4d2-e063-6394a90a6fa51
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSY2c3a502f-8e72-c4d2-e063-6394a90a6fa51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-700-15658620700151500 TABLET in 1 BAG (65862-700-15)1500 tablet29-MAR-06Current
65862-700-206586207002020 TABLET in 1 BOTTLE (65862-700-20) 20 tablet2006-03-290000-00-00NoNoCurrent
65862-700-606586207006060 TABLET in 1 BOTTLE (65862-700-60) 60 tablet2006-03-290000-00-00NoNoCurrent