FDA.reportPublic FDA data

LEVOFLOXACIN

Product NDC
61919-426
11-digit product format
619190426
Labeler code
61919
Product ID
61919-426_4f5b83f6-1a34-21ec-e063-6294a90a4560
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOFLOXACIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA202801
Marketing category
ANDA
Marketing start
2019-04-24
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, 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-426-072025-01-30C16284748780-12cef2736-5b32-d83d-e063-dadaa90ab31fLEVOFLOXACIN
61919-426-072025-01-30C16284748780-12cef2736-5b32-d83d-e063-dadaa90ab31fLEVOFLOXACIN
61919-426-102025-01-30C16284748780-12cef2736-5b32-d83d-e063-dadaa90ab31fLEVOFLOXACIN
61919-426-102025-01-30C16284748780-12cef2736-5b32-d83d-e063-dadaa90ab31fLEVOFLOXACIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-426-07LEVOFLOXACIN7 in 1 BOTTLETABLET, FILM COATED79
61919-426-10LEVOFLOXACIN10 in 1 BOTTLETABLET, FILM COATED109
61919-426-14LEVOFLOXACIN14 in 1 BOTTLETABLET, FILM COATED149

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-426LEVOFLOXACIN TABLET LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]7Current NDC, Legacy NDC, 3 package rows20230808_4f40d5fa-ebcc-516c-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199885levoFLOXacin 500 MG Oral TabletPSN4f40d5fa-ebcc-516c-e054-00144ff8d46c9
311296levoFLOXacin 750 MG Oral TabletPSN4f40d5fa-ebcc-516c-e054-00144ff8d46c9
199885levofloxacin 500 MG Oral TabletSCD4f40d5fa-ebcc-516c-e054-00144ff8d46c9
311296levofloxacin 750 MG Oral TabletSCD4f40d5fa-ebcc-516c-e054-00144ff8d46c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-426-07619190426077 TABLET, FILM COATED in 1 BOTTLE (61919-426-07) 2019-04-240000-00-00NoNoCurrent
61919-426-106191904261010 TABLET, FILM COATED in 1 BOTTLE (61919-426-10) 2019-04-240000-00-00NoNoCurrent
61919-426-146191904261414 TABLET, FILM COATED in 1 BOTTLE (61919-426-14) 2019-04-24NoNoCurrent