FDA.reportPublic FDA data

levofloxacin

Product NDC
72578-098
11-digit product format
725780098
Labeler code
72578
Product ID
72578-098_6295ff00-86a9-454c-987b-a1fe1c4386e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA077652
Marketing category
ANDA
Marketing start
2022-01-10
Substance
LEVOFLOXACIN
Active strength
250 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
LEVOFLOXACIN250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6GNT3Y5LMF
Rxcui199884, 199885, 311296

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
72578-098-01levofloxacin100 in 1 BOTTLETABLET, FILM COATED1003
72578-098-05levofloxacin500 in 1 BOTTLETABLET, FILM COATED5003
72578-098-18levofloxacin50 in 1 BOTTLETABLET, FILM COATED503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-098-18EA - Each72578-09871e6731f-69a9-4e6c-8b27-7ab33e417d3912022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-098LEVOFLOXACIN TABLET, FILM COATED [VIONA PHARMACEUTICALS INC]3Current NDC, Legacy NDC, 3 package rows20240629_0948bff7-efc6-4f0e-a9dd-adca5bdc7fc2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199884levoFLOXacin 250 MG Oral TabletPSN0948bff7-efc6-4f0e-a9dd-adca5bdc7fc23
199885levoFLOXacin 500 MG Oral TabletPSN0948bff7-efc6-4f0e-a9dd-adca5bdc7fc23
311296levoFLOXacin 750 MG Oral TabletPSN0948bff7-efc6-4f0e-a9dd-adca5bdc7fc23
199884levofloxacin 250 MG Oral TabletSCD0948bff7-efc6-4f0e-a9dd-adca5bdc7fc23
199885levofloxacin 500 MG Oral TabletSCD0948bff7-efc6-4f0e-a9dd-adca5bdc7fc23
311296levofloxacin 750 MG Oral TabletSCD0948bff7-efc6-4f0e-a9dd-adca5bdc7fc23
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSY0948bff7-efc6-4f0e-a9dd-adca5bdc7fc23
199884levoFLOXacin 250 MG Oral TabletPSN2cee61b7-be51-0fe5-e063-6294a90af9e31
199884levoFLOXacin 250 MG Oral TabletPSN5261da15-1b6c-fbe2-e063-6394a90ad85e1
199884levofloxacin 250 MG Oral TabletSCD2cee61b7-be51-0fe5-e063-6294a90af9e31
199884levofloxacin 250 MG Oral TabletSCD5261da15-1b6c-fbe2-e063-6394a90ad85e1
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSY2cee61b7-be51-0fe5-e063-6294a90af9e31
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSY5261da15-1b6c-fbe2-e063-6394a90ad85e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72578-098-0172578009801100 TABLET, FILM COATED in 1 BOTTLE (72578-098-01) 2022-01-100000-00-00YesNoCurrent
72578-098-0572578009805500 TABLET, FILM COATED in 1 BOTTLE (72578-098-05) 2022-01-100000-00-00YesNoCurrent
72578-098-187257800981850 TABLET, FILM COATED in 1 BOTTLE (72578-098-18) 2022-01-100000-00-00YesNoCurrent