Levofloxacin

Product NDC
0143-9775
11-digit product format
001439775
Labeler code
0143
Product ID
0143-9775_6ad21a7c-8e5b-4b61-8f11-d3cd921d8c12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET
Route
ORAL
Labeler
West-ward Pharmaceutical Corp
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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0143-9775-05e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0143-9775-20e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0143-9775-059bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0143-9775-209bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0143-9775-05110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0143-9775-20110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0143-9775-052019-10-29C16284748780-1960f7f55-d6a9-8e05-e053-dbdaa90a074a26656a51-7426-4051-805b-cbb612293ae5
0143-9775-202019-10-29C16284748780-1960f7f55-d6a9-8e05-e053-dbdaa90a074a26656a51-7426-4051-805b-cbb612293ae5