FDA.reportPublic FDA data

Cefuroxime Axetil

Product NDC
65862-699
11-digit product format
658620699
Labeler code
65862
Product ID
65862-699_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
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
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
65862-699-20Cefuroxime Axetil20 in 1 BOTTLETABLET2013
65862-699-60Cefuroxime Axetil60 in 1 BOTTLETABLET6013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-699-20EA - Each65862-699e30d4d4a-0e95-404e-9e2e-d66c8cbdd6a612014-04-03
65862-699-60EA - Each65862-69907e2d156-ed09-46e0-942d-62c5a383f17d12014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFUROXIME AXETILACTIVE INGREDIENTZ49QDT0J8ZCEFUROXIME AXETIL (CEFUROXIME AXETIL) TABLET [PD-RX PHARMACEUTICALS, INC.]9
CEFUROXIMEACTIVE MOIETYO1R9FJ93EDCEFUROXIME AXETIL (CEFUROXIME AXETIL) TABLET [PD-RX PHARMACEUTICALS, INC.]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEFUROXIME AXETIL (CEFUROXIME AXETIL) TABLET [PD-RX PHARMACEUTICALS, INC.]9
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CEFUROXIME AXETIL (CEFUROXIME AXETIL) TABLET [PD-RX PHARMACEUTICALS, INC.]9
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EACEFUROXIME AXETIL (CEFUROXIME AXETIL) TABLET [PD-RX PHARMACEUTICALS, INC.]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCEFUROXIME AXETIL (CEFUROXIME AXETIL) TABLET [PD-RX PHARMACEUTICALS, INC.]9
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCEFUROXIME AXETIL (CEFUROXIME AXETIL) TABLET [PD-RX PHARMACEUTICALS, INC.]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFUROXIME AXETIL (CEFUROXIME AXETIL) TABLET [PD-RX PHARMACEUTICALS, INC.]9
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEFUROXIME AXETIL (CEFUROXIME AXETIL) TABLET [PD-RX PHARMACEUTICALS, INC.]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFUROXIME AXETIL (CEFUROXIME AXETIL) TABLET [PD-RX PHARMACEUTICALS, INC.]9
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
CEFUROXIME AXETILACTIVE INGREDIENTZ49QDT0J8ZCEFUROXIME AXETIL TABLET [DIRECT RX]2
CEFUROXIMEACTIVE MOIETYO1R9FJ93EDCEFUROXIME AXETIL TABLET [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEFUROXIME AXETIL TABLET [DIRECT RX]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CEFUROXIME AXETIL TABLET [DIRECT RX]2
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EACEFUROXIME AXETIL TABLET [DIRECT RX]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCEFUROXIME AXETIL TABLET [DIRECT RX]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCEFUROXIME AXETIL TABLET [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFUROXIME AXETIL TABLET [DIRECT RX]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEFUROXIME AXETIL TABLET [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFUROXIME AXETIL TABLET [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-699CEFUROXIME 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
309097cefuroxime axetil 250 MG Oral TabletPSNa84ac4ed-c268-4e9f-9df8-256e0a64cd1621
309097cefuroxime 250 MG Oral TabletSCDa84ac4ed-c268-4e9f-9df8-256e0a64cd1621
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSYa84ac4ed-c268-4e9f-9df8-256e0a64cd1621
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
309097cefuroxime axetil 250 MG Oral TabletPSNa940ba01-2b53-4947-9019-d3d8f4e9ad806
309097cefuroxime axetil 250 MG Oral TabletPSN119c4d09-2324-498f-9318-1f8db49ad4b66
309097cefuroxime 250 MG Oral TabletSCDa940ba01-2b53-4947-9019-d3d8f4e9ad806
309097cefuroxime 250 MG Oral TabletSCD119c4d09-2324-498f-9318-1f8db49ad4b66
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSY119c4d09-2324-498f-9318-1f8db49ad4b66
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSYa940ba01-2b53-4947-9019-d3d8f4e9ad806
309097cefuroxime axetil 250 MG Oral TabletPSNd14d4184-3e29-43cd-8046-658699c70f033
309097cefuroxime 250 MG Oral TabletSCDd14d4184-3e29-43cd-8046-658699c70f033
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSYd14d4184-3e29-43cd-8046-658699c70f033
309097cefuroxime axetil 250 MG Oral TabletPSNad1a2f81-2595-47eb-9c2e-967c4b8e26bd2
309097cefuroxime 250 MG Oral TabletSCDad1a2f81-2595-47eb-9c2e-967c4b8e26bd2
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSYad1a2f81-2595-47eb-9c2e-967c4b8e26bd2
309097cefuroxime axetil 250 MG Oral TabletPSN2c619a79-6b69-b9fa-e063-6394a90a8f271
309097cefuroxime 250 MG Oral TabletSCD2c619a79-6b69-b9fa-e063-6394a90a8f271
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSY2c619a79-6b69-b9fa-e063-6394a90a8f271

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-699-206586206992020 TABLET in 1 BOTTLE (65862-699-20) 20 tablet2006-03-290000-00-00NoNoCurrent
65862-699-35658620699353500 TABLET in 1 BAG (65862-699-35)3500 tablet29-MAR-06Current
65862-699-606586206996060 TABLET in 1 BOTTLE (65862-699-60) 60 tablet2006-03-290000-00-00NoNoCurrent