FDA.reportPublic FDA data

levofloxacin

Product NDC
65841-692
11-digit product format
658410692
Labeler code
65841
Product ID
65841-692_5aeae448-e53f-4954-9dd9-2bcc3dd791d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA077652
Marketing category
ANDA
Marketing start
2010-11-10
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
65841-692-01levofloxacin100 in 1 BOTTLETABLET, FILM COATED10011
65841-692-05levofloxacin500 in 1 BOTTLETABLET, FILM COATED50011
65841-692-10levofloxacin1000 in 1 BOTTLETABLET, FILM COATED100011
65841-692-18levofloxacin50 in 1 BOTTLETABLET, FILM COATED5011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-692LEVOFLOXACIN TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]11Current NDC, Legacy NDC, 4 package rows20240821_ffa121b8-388f-4d7b-af48-d4aa8d9b5961.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199884levoFLOXacin 250 MG Oral TabletPSNffa121b8-388f-4d7b-af48-d4aa8d9b596111
199885levoFLOXacin 500 MG Oral TabletPSNffa121b8-388f-4d7b-af48-d4aa8d9b596111
311296levoFLOXacin 750 MG Oral TabletPSNffa121b8-388f-4d7b-af48-d4aa8d9b596111
199884levofloxacin 250 MG Oral TabletSCDffa121b8-388f-4d7b-af48-d4aa8d9b596111
199885levofloxacin 500 MG Oral TabletSCDffa121b8-388f-4d7b-af48-d4aa8d9b596111
311296levofloxacin 750 MG Oral TabletSCDffa121b8-388f-4d7b-af48-d4aa8d9b596111
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSYffa121b8-388f-4d7b-af48-d4aa8d9b596111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65841-692-0165841069201100 TABLET, FILM COATED in 1 BOTTLE (65841-692-01) 2012-11-100000-00-00NoNoCurrent
65841-692-0565841069205500 TABLET, FILM COATED in 1 BOTTLE (65841-692-05) 2012-11-100000-00-00NoNoCurrent
65841-692-10658410692101000 TABLET, FILM COATED in 1 BOTTLE (65841-692-10) 2012-11-100000-00-00NoNoCurrent
65841-692-186584106921850 TABLET, FILM COATED in 1 BOTTLE (65841-692-18) 2012-11-100000-00-00NoNoCurrent