FDA.reportPublic FDA data

Levofloxacin

Product NDC
71335-0794
11-digit product format
713350794
Labeler code
71335
Product ID
71335-0794_28839fd0-cbd5-482f-a30a-afbfe0709bef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202801
Marketing category
ANDA
Marketing start
2015-01-09
Substance
LEVOFLOXACIN
Active strength
250 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
LEVOFLOXACIN250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6GNT3Y5LMF
Rxcui199884

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
71335-0794-1Levofloxacin10 in 1 BOTTLETABLET, FILM COATED1017
71335-0794-2Levofloxacin20 in 1 BOTTLETABLET, FILM COATED2017
71335-0794-3Levofloxacin60 in 1 BOTTLETABLET, FILM COATED6017
71335-0794-4Levofloxacin30 in 1 BOTTLETABLET, FILM COATED3017
71335-0794-5Levofloxacin14 in 1 BOTTLETABLET, FILM COATED1417
71335-0794-6Levofloxacin3 in 1 BOTTLETABLET, FILM COATED317
71335-0794-7Levofloxacin5 in 1 BOTTLETABLET, FILM COATED517

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0794-2EA - Each71335-07944056e611-c8c2-4ae0-a617-a0708395eb2512025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0794LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [BRYANT RANCH PREPACK]17Current NDC, Legacy NDC, 7 package rows20240913_171ab6c6-8eb5-4716-926f-cee52b7d0968.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199884levoFLOXacin 250 MG Oral TabletPSN171ab6c6-8eb5-4716-926f-cee52b7d096817
199884levofloxacin 250 MG Oral TabletSCD171ab6c6-8eb5-4716-926f-cee52b7d096817
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSY171ab6c6-8eb5-4716-926f-cee52b7d096817

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0794-17133507940110 TABLET, FILM COATED in 1 BOTTLE (71335-0794-1) 2018-05-290000-00-00NoNoCurrent
71335-0794-27133507940220 TABLET, FILM COATED in 1 BOTTLE (71335-0794-2) 2024-09-050000-00-00NoNoCurrent
71335-0794-37133507940360 TABLET, FILM COATED in 1 BOTTLE (71335-0794-3) 2024-09-050000-00-00NoNoCurrent
71335-0794-47133507940430 TABLET, FILM COATED in 1 BOTTLE (71335-0794-4) 2023-04-200000-00-00NoNoCurrent
71335-0794-57133507940514 TABLET, FILM COATED in 1 BOTTLE (71335-0794-5) 2018-04-270000-00-00NoNoCurrent
71335-0794-6713350794063 TABLET, FILM COATED in 1 BOTTLE (71335-0794-6) 2021-11-020000-00-00NoNoCurrent
71335-0794-7713350794075 TABLET, FILM COATED in 1 BOTTLE (71335-0794-7) 2021-11-020000-00-00NoNoCurrent