FDA.reportPublic FDA data

Levofloxacin

Product NDC
50090-3214
11-digit product format
500903214
Labeler code
50090
Product ID
50090-3214_f0b328c3-8092-456e-a360-43166366b1ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202801
Marketing category
ANDA
Marketing start
2015-01-09
Substance
LEVOFLOXACIN
Active strength
750 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levofloxacin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOFLOXACIN750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6GNT3Y5LMF
Rxcui199884, 199885, 311296

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
50090-3214-02023-02-06C16284748780-1f386c649-e6d5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996
50090-3214-12023-02-06C16284748780-1f386c649-e6d5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996
50090-3214-22023-02-06C16284748780-1f386c649-e6d5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996
50090-3214-02023-01-30C16284748780-1f386c649-e6d5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996
50090-3214-12023-01-30C16284748780-1f386c649-e6d5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996
50090-3214-22023-01-30C16284748780-1f386c649-e6d5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3214-0Levofloxacin5 in 1 BOTTLETABLET, FILM COATED527
50090-3214-1Levofloxacin7 in 1 BOTTLE, PLASTICTABLET, FILM COATED727
50090-3214-2Levofloxacin10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1027

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3214LEVOFLOXACIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]20Current NDC, Legacy NDC, 3 package rows20230801_1538ec66-f385-401e-8cfb-d794691e7176.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199884levoFLOXacin 250 MG Oral TabletPSN1538ec66-f385-401e-8cfb-d794691e717627
199885levoFLOXacin 500 MG Oral TabletPSN1538ec66-f385-401e-8cfb-d794691e717627
311296levoFLOXacin 750 MG Oral TabletPSN1538ec66-f385-401e-8cfb-d794691e717627
199884levofloxacin 250 MG Oral TabletSCD1538ec66-f385-401e-8cfb-d794691e717627
199885levofloxacin 500 MG Oral TabletSCD1538ec66-f385-401e-8cfb-d794691e717627
311296levofloxacin 750 MG Oral TabletSCD1538ec66-f385-401e-8cfb-d794691e717627
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSY1538ec66-f385-401e-8cfb-d794691e717627

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3214-0500903214005 TABLET, FILM COATED in 1 BOTTLE (50090-3214-0) 2017-10-260000-00-00NoNoCurrent
50090-3214-1500903214017 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3214-1) 2015-01-090000-00-00NoNoCurrent
50090-3214-25009032140210 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3214-2) 2015-01-090000-00-00NoNoCurrent