FDA.reportPublic FDA data

Cefuroxime axetil

Product NDC
67877-215
11-digit product format
678770215
Labeler code
67877
Product ID
67877-215_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
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
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
67877-215-01Cefuroxime axetil100 in 1 BOTTLETABLET, FILM COATED10025
67877-215-20Cefuroxime axetil20 in 1 BOTTLETABLET, FILM COATED2025
67877-215-60Cefuroxime axetil60 in 1 BOTTLETABLET, FILM COATED6025
67877-215-84Cefuroxime axetil10 in 1 BLISTER PACKTABLET, FILM COATED1025
67877-215-84Cefuroxime axetil30 in 1 CARTONTABLET, FILM COATED3025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-215-20EA - Each67877-215c93a9e1c-0609-443c-8c59-b1c2fd2e8c4012012-07-24
67877-215-60EA - Each67877-2159d640c6f-5bc2-481c-b7f2-65b4975954bc12012-07-24

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
Cefuroxime axetilACTIVE INGREDIENTZ49QDT0J8ZCEFUROXIME AXETIL TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
CefuroximeACTIVE MOIETYO1R9FJ93EDCEFUROXIME AXETIL TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-215CEFUROXIME 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
309097cefuroxime axetil 250 MG Oral TabletPSN2af8f061-c0e1-3a1c-e054-00144ff8d46c24
309097cefuroxime 250 MG Oral TabletSCD2af8f061-c0e1-3a1c-e054-00144ff8d46c24
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSY2af8f061-c0e1-3a1c-e054-00144ff8d46c24
309097cefuroxime axetil 250 MG Oral TabletPSN2af94304-8118-41c7-e054-00144ff8d46c22
309097cefuroxime 250 MG Oral TabletSCD2af94304-8118-41c7-e054-00144ff8d46c22
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSY2af94304-8118-41c7-e054-00144ff8d46c22
309097cefuroxime axetil 250 MG Oral TabletPSN84593261-838c-433a-8d9d-1d37b11058da17
309097cefuroxime 250 MG Oral TabletSCD84593261-838c-433a-8d9d-1d37b11058da17
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSY84593261-838c-433a-8d9d-1d37b11058da17
309097cefuroxime axetil 250 MG Oral TabletPSNe9a020ec-e446-469a-b1d1-07e82eefa3055
309097cefuroxime 250 MG Oral TabletSCDe9a020ec-e446-469a-b1d1-07e82eefa3055
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSYe9a020ec-e446-469a-b1d1-07e82eefa3055
309097cefuroxime axetil 250 MG Oral TabletPSNb73bebbe-fd90-4e9b-864a-4906d8bab3053
309097cefuroxime axetil 250 MG Oral TabletPSN8c3c1c85-cbce-66e2-e053-2a95a90a94fe3
309097cefuroxime 250 MG Oral TabletSCDb73bebbe-fd90-4e9b-864a-4906d8bab3053
309097cefuroxime 250 MG Oral TabletSCD8c3c1c85-cbce-66e2-e053-2a95a90a94fe3
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSYb73bebbe-fd90-4e9b-864a-4906d8bab3053
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSY8c3c1c85-cbce-66e2-e053-2a95a90a94fe3
309097cefuroxime axetil 250 MG Oral TabletPSN90001905-36e4-b0e1-e053-2995a90a4d932
309097cefuroxime axetil 250 MG Oral TabletPSN1bc56a86-735c-4787-826a-9bb59027fa092
309097cefuroxime 250 MG Oral TabletSCD90001905-36e4-b0e1-e053-2995a90a4d932
309097cefuroxime 250 MG Oral TabletSCD1bc56a86-735c-4787-826a-9bb59027fa092
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSY1bc56a86-735c-4787-826a-9bb59027fa092
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSY90001905-36e4-b0e1-e053-2995a90a4d932

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-215-0167877021501100 TABLET, FILM COATED in 1 BOTTLE (67877-215-01) 2010-12-010000-00-00NoNoCurrent
67877-215-206787702152020 TABLET, FILM COATED in 1 BOTTLE (67877-215-20) 2010-12-010000-00-00NoNoCurrent
67877-215-606787702156060 TABLET, FILM COATED in 1 BOTTLE (67877-215-60) 2010-12-010000-00-00NoNoCurrent
67877-215-846787702158430 BLISTER PACK in 1 CARTON (67877-215-84) / 10 TABLET, FILM COATED in 1 BLISTER PACK30 blister pack2010-12-010000-00-00NoNoCurrent