Cefuroxime axetil

Product NDC
63629-9446
11-digit product format
636299446
Labeler code
63629
Product ID
63629-9446_91899c7f-a472-48c0-b879-9395fc0088ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime axetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA065496
Marketing category
ANDA
Marketing start
2010-12-01
Marketing end
0000-00-00
Substance
CEFUROXIME AXETIL
Active strength
250 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9446-1EA - Each63629-9446b5f15e5d-c340-4e02-a4e7-edbd615f29f112022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9446CEFUROXIME AXETIL TABLET, FILM COATED [BRYANT RANCH PREPACK]101Legacy NDC20230317_0303526e-6781-4d38-adf9-13903722d937.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-9446-16362994460120 TABLET, FILM COATED in 1 BOTTLE (63629-9446-1) 2022-09-280000-00-00NoNoCurrent