FDA.reportPublic FDA data

Cefuroxime axetil

Product NDC
67877-216
11-digit product format
678770216
Labeler code
67877
Product ID
67877-216_7c9fa966-9491-40a8-a57b-6f60dbf7bb55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime axetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA065496
Marketing category
ANDA
Marketing start
2010-12-01
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
67877-216-01Cefuroxime axetil100 in 1 BOTTLETABLET, FILM COATED10025
67877-216-20Cefuroxime axetil20 in 1 BOTTLETABLET, FILM COATED2025
67877-216-60Cefuroxime axetil60 in 1 BOTTLETABLET, FILM COATED6025
67877-216-84Cefuroxime axetil30 in 1 CARTONTABLET, FILM COATED3025
67877-216-84Cefuroxime axetil10 in 1 BLISTER PACKTABLET, FILM COATED1025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-216-20EA - Each67877-216065e1f95-1ad2-41b2-a585-0d2146a2ed1112012-07-24
67877-216-60EA - Each67877-216e726e0fe-c125-4e8f-aa99-b50b7003339212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cefuroxime axetilACTIVE INGREDIENTZ49QDT0J8ZCEFUROXIME AXETIL TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8
CefuroximeACTIVE MOIETYO1R9FJ93EDCEFUROXIME AXETIL TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CEFUROXIME AXETIL TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKCEFUROXIME AXETIL TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LCEFUROXIME AXETIL TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEFUROXIME AXETIL TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFUROXIME AXETIL TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CEFUROXIME AXETIL TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCEFUROXIME AXETIL TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEFUROXIME AXETIL TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CEFUROXIME AXETIL TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEFUROXIME AXETIL TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEFUROXIME AXETIL TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFUROXIME AXETIL TABLET, FILM COATED [ASCEND LABORATORIES, LLC]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-216CEFUROXIME AXETIL TABLET, FILM COATED [ASCEND LABORATORIES, LLC]24Current NDC, Legacy NDC, 5 package rows20230202_dd11e4b9-7730-4d3a-81ca-16f15de09759.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309097cefuroxime axetil 250 MG Oral TabletPSNc89e8f4d-96c0-44c6-906a-b803141920b127
309098cefuroxime axetil 500 MG Oral TabletPSNc89e8f4d-96c0-44c6-906a-b803141920b127
309097cefuroxime 250 MG Oral TabletSCDc89e8f4d-96c0-44c6-906a-b803141920b127
309098cefuroxime 500 MG Oral TabletSCDc89e8f4d-96c0-44c6-906a-b803141920b127
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSYc89e8f4d-96c0-44c6-906a-b803141920b127
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSYc89e8f4d-96c0-44c6-906a-b803141920b127
309097cefuroxime axetil 250 MG Oral TabletPSNdd11e4b9-7730-4d3a-81ca-16f15de0975925
309098cefuroxime axetil 500 MG Oral TabletPSNdd11e4b9-7730-4d3a-81ca-16f15de0975925
309097cefuroxime 250 MG Oral TabletSCDdd11e4b9-7730-4d3a-81ca-16f15de0975925
309098cefuroxime 500 MG Oral TabletSCDdd11e4b9-7730-4d3a-81ca-16f15de0975925
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSYdd11e4b9-7730-4d3a-81ca-16f15de0975925
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSYdd11e4b9-7730-4d3a-81ca-16f15de0975925
309098cefuroxime axetil 500 MG Oral TabletPSN15cabe73-f39d-4798-a840-115fe94f8f9624
309098cefuroxime 500 MG Oral TabletSCD15cabe73-f39d-4798-a840-115fe94f8f9624
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSY15cabe73-f39d-4798-a840-115fe94f8f9624
309098cefuroxime axetil 500 MG Oral TabletPSN3744f28c-c7e1-259c-e063-6294a90a10ed4
309098cefuroxime axetil 500 MG Oral TabletPSN83476d51-be74-748b-e053-2a91aa0a3d364
309098cefuroxime 500 MG Oral TabletSCD83476d51-be74-748b-e053-2a91aa0a3d364
309098cefuroxime 500 MG Oral TabletSCD3744f28c-c7e1-259c-e063-6294a90a10ed4
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSY3744f28c-c7e1-259c-e063-6294a90a10ed4
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSY83476d51-be74-748b-e053-2a91aa0a3d364
309098cefuroxime axetil 500 MG Oral TabletPSN418179e9-a533-4657-ae5a-848d1d187d763
309098cefuroxime 500 MG Oral TabletSCD418179e9-a533-4657-ae5a-848d1d187d763
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSY418179e9-a533-4657-ae5a-848d1d187d763
309098cefuroxime axetil 500 MG Oral TabletPSN48d96608-d3da-b512-e063-6294a90a07d51
309098cefuroxime axetil 500 MG Oral TabletPSN4e4426a4-0ca9-dad5-e063-6294a90a5fdb1
309098cefuroxime axetil 500 MG Oral TabletPSN1fbf8867-b17a-1016-e063-6394a90afe9d1
309098cefuroxime 500 MG Oral TabletSCD4e4426a4-0ca9-dad5-e063-6294a90a5fdb1
309098cefuroxime 500 MG Oral TabletSCD1fbf8867-b17a-1016-e063-6394a90afe9d1
309098cefuroxime 500 MG Oral TabletSCD48d96608-d3da-b512-e063-6294a90a07d51
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSY48d96608-d3da-b512-e063-6294a90a07d51
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSY1fbf8867-b17a-1016-e063-6394a90afe9d1
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSY4e4426a4-0ca9-dad5-e063-6294a90a5fdb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-216-0167877021601100 TABLET, FILM COATED in 1 BOTTLE (67877-216-01) 2010-12-010000-00-00NoNoCurrent
67877-216-206787702162020 TABLET, FILM COATED in 1 BOTTLE (67877-216-20) 2010-12-010000-00-00NoNoCurrent
67877-216-606787702166060 TABLET, FILM COATED in 1 BOTTLE (67877-216-60) 2010-12-010000-00-00NoNoCurrent
67877-216-846787702168430 BLISTER PACK in 1 CARTON (67877-216-84) / 10 TABLET, FILM COATED in 1 BLISTER PACK30 blister pack2010-12-010000-00-00NoNoCurrent