FDA.reportPublic FDA data

levofloxacin

Product NDC
71335-2265
11-digit product format
713352265
Labeler code
71335
Product ID
71335-2265_477d7d9e-1637-4c49-b588-f1da546a67f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077652
Marketing category
ANDA
Marketing start
2022-01-10
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
Rxcui311296

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
71335-2265-0levofloxacin3 in 1 BOTTLETABLET, FILM COATED3102
71335-2265-1levofloxacin10 in 1 BOTTLETABLET, FILM COATED10102
71335-2265-2levofloxacin30 in 1 BOTTLETABLET, FILM COATED30102
71335-2265-3levofloxacin7 in 1 BOTTLETABLET, FILM COATED7102
71335-2265-4levofloxacin20 in 1 BOTTLETABLET, FILM COATED20102
71335-2265-5levofloxacin5 in 1 BOTTLETABLET, FILM COATED5102
71335-2265-6levofloxacin14 in 1 BOTTLETABLET, FILM COATED14102
71335-2265-7levofloxacin28 in 1 BOTTLETABLET, FILM COATED28102
71335-2265-8levofloxacin60 in 1 BOTTLETABLET, FILM COATED60102
71335-2265-9levofloxacin90 in 1 BOTTLETABLET, FILM COATED90102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2265LEVOFLOXACIN TABLET, FILM COATED [BRYANT RANCH PREPACK]101Current NDC, 10 package rows20240726_cbd5153f-fada-4682-b858-dc3b6e3173cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311296levoFLOXacin 750 MG Oral TabletPSNcbd5153f-fada-4682-b858-dc3b6e3173cc102
311296levofloxacin 750 MG Oral TabletSCDcbd5153f-fada-4682-b858-dc3b6e3173cc102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2265-0713352265003 TABLET, FILM COATED in 1 BOTTLE (71335-2265-0) 2024-07-25NoNoHistorical
71335-2265-17133522650110 TABLET, FILM COATED in 1 BOTTLE (71335-2265-1) 2023-11-27NoNoHistorical
71335-2265-27133522650230 TABLET, FILM COATED in 1 BOTTLE (71335-2265-2) 2023-12-06NoNoHistorical
71335-2265-3713352265037 TABLET, FILM COATED in 1 BOTTLE (71335-2265-3) 2023-10-24NoNoHistorical
71335-2265-47133522650420 TABLET, FILM COATED in 1 BOTTLE (71335-2265-4) 2024-04-15NoNoHistorical
71335-2265-5713352265055 TABLET, FILM COATED in 1 BOTTLE (71335-2265-5) 2023-11-07NoNoHistorical
71335-2265-67133522650614 TABLET, FILM COATED in 1 BOTTLE (71335-2265-6) 2024-01-17NoNoHistorical
71335-2265-77133522650728 TABLET, FILM COATED in 1 BOTTLE (71335-2265-7) 2024-07-25NoNoHistorical
71335-2265-87133522650860 TABLET, FILM COATED in 1 BOTTLE (71335-2265-8) 2024-07-25NoNoHistorical
71335-2265-97133522650990 TABLET, FILM COATED in 1 BOTTLE (71335-2265-9) 2024-07-25NoNoHistorical