FDA.reportPublic FDA data

Levofloxacin

Product NDC
51655-666
11-digit product format
516550666
Labeler code
51655
Product ID
51655-666_4a664b9b-f8ce-2ae4-e063-6394a90a5355
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA076710
Marketing category
ANDA
Marketing start
2023-01-08
Substance
LEVOFLOXACIN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levofloxacin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOFLOXACIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6GNT3Y5LMF
Rxcui199885

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
51655-666-072026-01-29C16284748780-149896155-d15f-586f-e063-e6dba90add90These 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
51655-666-532026-01-29C16284748780-149896155-d15f-586f-e063-e6dba90add90These 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
51655-666-842026-01-29C16284748780-149896155-d15f-586f-e063-e6dba90add90These 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
51655-666-07Levofloxacin7 in 1 BOTTLE, PLASTICTABLET, FILM COATED74
51655-666-53Levofloxacin10 in 1 BOTTLETABLET, FILM COATED104
51655-666-84Levofloxacin14 in 1 BOTTLE, PLASTICTABLET, FILM COATED144

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-666LEVOFLOXACIN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 3 package rows20230630_f33140d5-59ad-3379-e053-2995a90ae286.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199885levoFLOXacin 500 MG Oral TabletPSNf33140d5-59ad-3379-e053-2995a90ae2864
199885levofloxacin 500 MG Oral TabletSCDf33140d5-59ad-3379-e053-2995a90ae2864

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-666-07516550666077 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-666-07) 2023-04-03NoNoCurrent
51655-666-535165506665310 TABLET, FILM COATED in 1 BOTTLE (51655-666-53) 2023-01-08NoNoCurrent
51655-666-845165506668414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-666-84) 2023-05-03NoNoCurrent