FDA.reportPublic FDA data

Levofloxacin

Product NDC
72189-338
11-digit product format
721890338
Labeler code
72189
Product ID
72189-338_2c3d9c0f-6e78-fa93-e063-6394a90a6dbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DirectRx
Application
ANDA202801
Marketing category
ANDA
Marketing start
2022-03-21
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
72189-338-05Levofloxacin5 in 1 BOTTLETABLET, FILM COATED55
72189-338-07Levofloxacin7 in 1 BOTTLETABLET, FILM COATED75
72189-338-10Levofloxacin10 in 1 BOTTLETABLET, FILM COATED105
72189-338-14Levofloxacin14 in 1 BOTTLETABLET, FILM COATED145

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-338-05EA - Each72189-338614a8b37-9dc6-4c74-8c60-335db748fde412023-06-06
72189-338-07EA - Each72189-338b0835731-ba58-4ea6-ad23-3c10a1dd2f5e12022-04-06
72189-338-10EA - Each72189-338a31acbc8-ddb9-40a1-827d-0407c3c1920e12022-07-06
72189-338-14EA - Each72189-338bc643bea-dabf-4eab-93fb-b19b0b624abc12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-338LEVOFLOXACIN TABLET, FILM COATED [DIRECTRX]5Current NDC, Legacy NDC, 4 package rows20250122_dabedb15-5b55-3853-e053-2995a90aa44e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311296levoFLOXacin 750 MG Oral TabletPSNdabedb15-5b55-3853-e053-2995a90aa44e5
311296levofloxacin 750 MG Oral TabletSCDdabedb15-5b55-3853-e053-2995a90aa44e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-338-05721890338055 TABLET, FILM COATED in 1 BOTTLE (72189-338-05) 2022-03-21NoNoCurrent
72189-338-07721890338077 TABLET, FILM COATED in 1 BOTTLE (72189-338-07) 2022-03-210000-00-00NoNoCurrent
72189-338-107218903381010 TABLET, FILM COATED in 1 BOTTLE (72189-338-10) 2022-03-210000-00-00NoNoCurrent
72189-338-147218903381414 TABLET, FILM COATED in 1 BOTTLE (72189-338-14) 2022-03-210000-00-00NoNoCurrent