Home NDC 59115-097 Levofloxacin
Product NDC 59115-097
11-digit product format 591150097
Labeler code 59115
Product ID 59115-097_9efe5654-c187-4c9a-a702-2317f5600b6d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levofloxacin
Dosage form TABLET
Route ORAL
Labeler Hikma Pharmaceutical
Application ANDA078767
Marketing category ANDA
Marketing start 2011-06-21
Marketing end 0000-00-00
Substance LEVOFLOXACIN
Active strength 750 mg/1
Pharmacologic classes Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 59115-097-55 e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 59115-097-22 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 59115-097-55 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 59115-097-22 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 59115-097-55 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 59115-097-22 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog .
FDA-Initiated Inactive NDC Indexing#