FDA.reportPublic FDA data

Cefuroxime Axetil

Product NDC
57237-059
11-digit product format
572370059
Labeler code
57237
Product ID
57237-059_d7e9c50b-74c7-4c0b-9c73-8802fa288cd8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime Axetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
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
57237-059-20Cefuroxime Axetil20 in 1 BOTTLETABLET, FILM COATED2010
57237-059-60Cefuroxime Axetil60 in 1 BOTTLETABLET, FILM COATED6010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-059-20EA - Each57237-0594de04de3-e2da-4bb3-bcec-ef334495596912014-04-03
57237-059-60EA - Each57237-059206612a3-36e2-4a5b-a200-a1e4c2041dde12014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFUROXIME AXETILACTIVE INGREDIENTZ49QDT0J8ZCEFUROXIME AXETIL TABLET, FILM COATED [CITRON PHARMA LLC]3
CEFUROXIMEACTIVE MOIETYO1R9FJ93EDCEFUROXIME AXETIL TABLET, FILM COATED [CITRON PHARMA LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEFUROXIME AXETIL TABLET, FILM COATED [CITRON PHARMA LLC]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CEFUROXIME AXETIL TABLET, FILM COATED [CITRON PHARMA LLC]3
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EACEFUROXIME AXETIL TABLET, FILM COATED [CITRON PHARMA LLC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCEFUROXIME AXETIL TABLET, FILM COATED [CITRON PHARMA LLC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACEFUROXIME AXETIL TABLET, FILM COATED [CITRON PHARMA LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFUROXIME AXETIL TABLET, FILM COATED [CITRON PHARMA LLC]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEFUROXIME AXETIL TABLET, FILM COATED [CITRON PHARMA LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFUROXIME AXETIL TABLET, FILM COATED [CITRON PHARMA LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-059CEFUROXIME AXETIL TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]10Current NDC, Legacy NDC, 2 package rows20240503_66f8d37f-aebc-4435-af80-dfd7b3770088.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309097cefuroxime axetil 250 MG Oral TabletPSN66f8d37f-aebc-4435-af80-dfd7b377008810
309098cefuroxime axetil 500 MG Oral TabletPSN66f8d37f-aebc-4435-af80-dfd7b377008810
309097cefuroxime 250 MG Oral TabletSCD66f8d37f-aebc-4435-af80-dfd7b377008810
309098cefuroxime 500 MG Oral TabletSCD66f8d37f-aebc-4435-af80-dfd7b377008810
309097cefuroxime (as cefuroxime axetil) 250 MG Oral TabletSY66f8d37f-aebc-4435-af80-dfd7b377008810
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSY66f8d37f-aebc-4435-af80-dfd7b377008810
309098cefuroxime axetil 500 MG Oral TabletPSN76cec54f-d167-4298-951b-5411a3c47f4a9
309098cefuroxime 500 MG Oral TabletSCD76cec54f-d167-4298-951b-5411a3c47f4a9
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSY76cec54f-d167-4298-951b-5411a3c47f4a9
309098cefuroxime axetil 500 MG Oral TabletPSN0ab07b73-7830-f2b4-e063-6294a90a4d8d2
309098cefuroxime 500 MG Oral TabletSCD0ab07b73-7830-f2b4-e063-6294a90a4d8d2
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSY0ab07b73-7830-f2b4-e063-6294a90a4d8d2
309098cefuroxime axetil 500 MG Oral TabletPSN3f92c452-18b4-5af8-e063-6394a90aaa531
309098cefuroxime axetil 500 MG Oral TabletPSNbc9200d2-4a6d-4847-ba85-8e9d378390de1
309098cefuroxime axetil 500 MG Oral TabletPSNf75c5f90-9c8a-c63e-e053-6394a90a26921
309098cefuroxime 500 MG Oral TabletSCD3f92c452-18b4-5af8-e063-6394a90aaa531
309098cefuroxime 500 MG Oral TabletSCDbc9200d2-4a6d-4847-ba85-8e9d378390de1
309098cefuroxime 500 MG Oral TabletSCDf75c5f90-9c8a-c63e-e053-6394a90a26921
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSY3f92c452-18b4-5af8-e063-6394a90aaa531
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSYbc9200d2-4a6d-4847-ba85-8e9d378390de1
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSYf75c5f90-9c8a-c63e-e053-6394a90a26921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57237-059-205723700592020 TABLET, FILM COATED in 1 BOTTLE (57237-059-20) 2006-03-290000-00-00NoNoCurrent
57237-059-605723700596060 TABLET, FILM COATED in 1 BOTTLE (57237-059-60) 2006-03-290000-00-00NoNoCurrent