Cefuroxime Axetil

Product NDC
55289-385
11-digit product format
552890385
Labeler code
55289
Product ID
55289-385_d2908a67-9891-3749-e053-2a95a90a2591
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime Axetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA065166
Marketing category
ANDA
Marketing start
2005-07-29
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-385-04EA - Each55289-3850c95b825-1e0f-4d2d-8321-0c9dc1c0050312012-07-24
55289-385-30EA - Each55289-385ad1c5b7a-d233-4704-8731-b662052a8def12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55289-385-04552890385044 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-385-04) 2012-02-020000-00-00NoNoCurrent
55289-385-305528903853030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-385-30) 2012-02-020000-00-00NoNoCurrent