FDA.reportPublic FDA data

Levofloxacin

Product NDC
50090-3311
11-digit product format
500903311
Labeler code
50090
Product ID
50090-3311_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
500 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
LEVOFLOXACIN500 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3311-0Levofloxacin7 in 1 BOTTLETABLET, FILM COATED727
50090-3311-1Levofloxacin10 in 1 BOTTLETABLET, FILM COATED1027
50090-3311-4Levofloxacin14 in 1 BOTTLETABLET, FILM COATED1427

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3311LEVOFLOXACIN 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 startSampleExclude flagStatus
50090-3311-0500903311007 TABLET, FILM COATED in 1 BOTTLE (50090-3311-0) 2018-02-01NoNoCurrent
50090-3311-15009033110110 TABLET, FILM COATED in 1 BOTTLE (50090-3311-1) 2017-12-22NoNoCurrent
50090-3311-45009033110414 TABLET, FILM COATED in 1 BOTTLE (50090-3311-4) 2018-02-05NoNoCurrent