FDA.reportPublic FDA data

Levofloxacin

Product NDC
68071-3093
11-digit product format
680713093
Labeler code
68071
Product ID
68071-3093_1d9cfa8e-ef8b-221c-e063-6394a90a078d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA202801
Marketing category
ANDA
Marketing start
2015-01-09
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

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
68071-3093-22024-07-26C16284748780-19d75b9d0-ae46-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN Tablet, Film Coated for Oral use Initial U.S. Approval: 1996
68071-3093-32024-07-26C16284748780-19d75b9d0-ae46-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN Tablet, Film Coated for Oral use Initial U.S. Approval: 1996
68071-3093-22023-01-30C16284748780-19d75b9d0-ae46-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN Tablet, Film Coated for Oral use Initial U.S. Approval: 1996
68071-3093-32023-01-30C16284748780-19d75b9d0-ae46-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN Tablet, Film Coated for Oral use Initial U.S. Approval: 1996
68071-3093-22020-03-17C16284748780-19d75b9d0-ae46-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN Tablet, Film Coated for Oral use Initial U.S. Approval: 1996
68071-3093-22020-01-31C16284748780-19d75b9d0-ae46-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN Tablet, Film Coated for Oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3093-2Levofloxacin20 in 1 BOTTLETABLET, FILM COATED204
68071-3093-3Levofloxacin30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3093LEVOFLOXACIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 2 package rows20240727_4a405103-41e8-6a1f-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199884levoFLOXacin 250 MG Oral TabletPSN4a405103-41e8-6a1f-e054-00144ff8d46c4
199884levofloxacin 250 MG Oral TabletSCD4a405103-41e8-6a1f-e054-00144ff8d46c4
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSY4a405103-41e8-6a1f-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-3093-26807130930220 TABLET, FILM COATED in 1 BOTTLE (68071-3093-2) 2017-03-080000-00-00NoNoCurrent
68071-3093-36807130930330 TABLET, FILM COATED in 1 BOTTLE (68071-3093-3) 2017-03-080000-00-00NoNoCurrent