FDA.reportPublic FDA data

Levofloxacin

Product NDC
33261-793
11-digit product format
332610793
Labeler code
33261
Product ID
33261-793_5de98130-babf-405b-994a-d117eef9ef57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA090367
Marketing category
ANDA
Marketing start
2011-06-20
Marketing end
0000-00-00
Substance
LEVOFLOXACIN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
addb5519-f7ae-4d4e-b9ca-f782a1597fd3Product name220210610
fb758c6a-fdee-40a8-99c2-46f79c3ff90cProduct name420200807
1a81e9a9-11c3-4fcf-b5dd-f6798fef8e6dProduct name120190618
aea4a616-4dfe-45f6-94bb-8b9063056cebProduct name620190611
2246ce8e-a477-4dc3-b6d6-fe9973c18ed1Product name120180821
5a6c788d-375b-4565-a8ae-67c179a30c93Product name120180212

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-793-052020-01-31C16284748780-19d75b9d0-75df-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Levofloxacin safely and effectively. See full prescribing information for Levofloxacin. Levofloxacin Tablets Initial U.S. Approval: 1996
33261-793-072020-01-31C16284748780-19d75b9d0-75df-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Levofloxacin safely and effectively. See full prescribing information for Levofloxacin. Levofloxacin Tablets Initial U.S. Approval: 1996
33261-793-102020-01-31C16284748780-19d75b9d0-75df-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Levofloxacin safely and effectively. See full prescribing information for Levofloxacin. Levofloxacin Tablets Initial U.S. Approval: 1996
33261-793-142020-01-31C16284748780-19d75b9d0-75df-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Levofloxacin safely and effectively. See full prescribing information for Levofloxacin. Levofloxacin Tablets Initial U.S. Approval: 1996
33261-793-202020-01-31C16284748780-19d75b9d0-75df-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Levofloxacin safely and effectively. See full prescribing information for Levofloxacin. Levofloxacin Tablets Initial U.S. Approval: 1996
33261-793-302020-01-31C16284748780-19d75b9d0-75df-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Levofloxacin safely and effectively. See full prescribing information for Levofloxacin. Levofloxacin Tablets Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-793-05Levofloxacin5 in 1 BOTTLE, PLASTICTABLET51
33261-793-07Levofloxacin7 in 1 BOTTLE, PLASTICTABLET71
33261-793-10Levofloxacin10 in 1 BOTTLE, PLASTICTABLET101
33261-793-14Levofloxacin14 in 1 BOTTLE, PLASTICTABLET141
33261-793-20Levofloxacin20 in 1 BOTTLE, PLASTICTABLET201
33261-793-30Levofloxacin30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-793LEVOFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 6 package rows20140110_56e8ffbe-59a6-4f6a-b2f9-43b4e339ef6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199884levoFLOXacin 250 MG Oral TabletPSN56e8ffbe-59a6-4f6a-b2f9-43b4e339ef6b1
199885levoFLOXacin 500 MG Oral TabletPSN56e8ffbe-59a6-4f6a-b2f9-43b4e339ef6b1
311296levoFLOXacin 750 MG Oral TabletPSN56e8ffbe-59a6-4f6a-b2f9-43b4e339ef6b1
199884levofloxacin 250 MG Oral TabletSCD56e8ffbe-59a6-4f6a-b2f9-43b4e339ef6b1
199885levofloxacin 500 MG Oral TabletSCD56e8ffbe-59a6-4f6a-b2f9-43b4e339ef6b1
311296levofloxacin 750 MG Oral TabletSCD56e8ffbe-59a6-4f6a-b2f9-43b4e339ef6b1
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSY56e8ffbe-59a6-4f6a-b2f9-43b4e339ef6b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-793-05332610793055 in 1 BOTTLE, PLASTICHistorical
33261-793-07332610793077 in 1 BOTTLE, PLASTICHistorical
33261-793-103326107931010 in 1 BOTTLE, PLASTICHistorical
33261-793-143326107931414 in 1 BOTTLE, PLASTICHistorical
33261-793-203326107932020 in 1 BOTTLE, PLASTICHistorical
33261-793-303326107933030 in 1 BOTTLE, PLASTICHistorical