Cefuroxime axetil

Product NDC
63629-9447
11-digit product format
636299447
Labeler code
63629
Product ID
63629-9447_390a1a44-bf05-4d02-9239-21aa74a328cc
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
63629-9447-1EA - Each63629-9447fa5ed5ed-ade9-4672-ae6b-a23af3d7338712022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9447CEFUROXIME AXETIL TABLET, FILM COATED [BRYANT RANCH PREPACK]101Legacy NDC20230317_0d2a0215-efbb-4975-a2f6-fe32ae4d5cb2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-9447-16362994470160 TABLET, FILM COATED in 1 BOTTLE (63629-9447-1) 2022-09-280000-00-00NoNoCurrent