Cefuroxime axetil

Product NDC
63629-9449
11-digit product format
636299449
Labeler code
63629
Product ID
63629-9449_6fcb367f-e4e8-4e3b-b4f7-0bc6c2eb0e5e
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
500 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
63629-9449-1EA - Each63629-94496cedf472-94fb-4e12-8273-38886898241b12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9449CEFUROXIME AXETIL TABLET, FILM COATED [BRYANT RANCH PREPACK]101Legacy NDC20230317_96f84bff-fce4-45d4-af2a-a2e4de7c9103.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-9449-16362994490160 TABLET, FILM COATED in 1 BOTTLE (63629-9449-1) 2022-09-280000-00-00NoNoCurrent