FDA.reportPublic FDA data

Cefuroxime axetil

Product NDC
63187-991
11-digit product format
631870991
Labeler code
63187
Product ID
63187-991_8251b1f4-6da1-461e-9512-fed77a1f402b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime axetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
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

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
63187-991-20Cefuroxime axetil20 in 1 BOTTLETABLET, FILM COATED205
63187-991-60Cefuroxime axetil60 in 1 BOTTLETABLET, FILM COATED605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-991-20EA - Each63187-991e270a243-579d-4c3e-b3f7-bc2a54ba8ce312018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-991CEFUROXIME AXETIL TABLET, FILM COATED [PROFICIENT RX LP]5Current NDC, Legacy NDC, 2 package rows20230707_e9a020ec-e446-469a-b1d1-07e82eefa305.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-991-206318709912020 TABLET, FILM COATED in 1 BOTTLE (63187-991-20) 2018-03-010000-00-00NoNoCurrent
63187-991-606318709916060 TABLET, FILM COATED in 1 BOTTLE (63187-991-60) 2010-12-010000-00-00NoNoCurrent