FDA.reportPublic FDA data

Levofloxacin

Product NDC
53002-2350
11-digit product format
530022350
Labeler code
53002
Product ID
53002-2350_0b2a71e5-7e92-425b-a2e6-0f246504d3eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA201043
Marketing category
ANDA
Marketing start
2011-06-20
Marketing end
0000-00-00
Substance
LEVOFLOXACIN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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
53002-2350-12025-01-30C16284748780-1f386c649-e02b-0266-e053-dadaa90a7c1aThese 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
53002-2350-32025-01-30C16284748780-1f386c649-e02b-0266-e053-dadaa90a7c1aThese 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
53002-2350-52025-01-30C16284748780-1f386c649-e02b-0266-e053-dadaa90a7c1aThese 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
53002-2350-72025-01-30C16284748780-1f386c649-e02b-0266-e053-dadaa90a7c1aThese 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
53002-2350-92025-01-30C16284748780-1f386c649-e02b-0266-e053-dadaa90a7c1aThese 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
53002-2350-12023-06-07C16284748780-1f386c649-e02b-0266-e053-dadaa90a7c1aThese 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
53002-2350-32023-06-07C16284748780-1f386c649-e02b-0266-e053-dadaa90a7c1aThese 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
53002-2350-52023-06-07C16284748780-1f386c649-e02b-0266-e053-dadaa90a7c1aThese 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
53002-2350-72023-06-07C16284748780-1f386c649-e02b-0266-e053-dadaa90a7c1aThese 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
53002-2350-92023-06-07C16284748780-1f386c649-e02b-0266-e053-dadaa90a7c1aThese 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
53002-2350-12023-01-30C16284748780-1f386c649-e02b-0266-e053-dadaa90a7c1aThese 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
53002-2350-32023-01-30C16284748780-1f386c649-e02b-0266-e053-dadaa90a7c1aThese 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
53002-2350-52023-01-30C16284748780-1f386c649-e02b-0266-e053-dadaa90a7c1aThese 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
53002-2350-72023-01-30C16284748780-1f386c649-e02b-0266-e053-dadaa90a7c1aThese 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
53002-2350-92023-01-30C16284748780-1f386c649-e02b-0266-e053-dadaa90a7c1aThese 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
53002-2350-1Levofloxacin10 in 1 BOTTLETABLET, FILM COATED103
53002-2350-3Levofloxacin3 in 1 BOTTLETABLET, FILM COATED33
53002-2350-5Levofloxacin5 in 1 BOTTLETABLET, FILM COATED53
53002-2350-7Levofloxacin7 in 1 BOTTLETABLET, FILM COATED73
53002-2350-9Levofloxacin14 in 1 BOTTLETABLET, FILM COATED143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2350LEVOFLOXACIN TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 5 package rows20230609_638e4e2c-ba0d-43f7-87a0-1b860a9e651a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199885levoFLOXacin 500 MG Oral TabletPSN638e4e2c-ba0d-43f7-87a0-1b860a9e651a3
199885levofloxacin 500 MG Oral TabletSCD638e4e2c-ba0d-43f7-87a0-1b860a9e651a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-2350-15300223500110 TABLET, FILM COATED in 1 BOTTLE (53002-2350-1) 2019-01-010000-00-00NoNoCurrent
53002-2350-3530022350033 TABLET, FILM COATED in 1 BOTTLE (53002-2350-3) 2019-01-010000-00-00NoNoCurrent
53002-2350-5530022350055 TABLET, FILM COATED in 1 BOTTLE (53002-2350-5) 2019-01-010000-00-00NoNoCurrent
53002-2350-7530022350077 TABLET, FILM COATED in 1 BOTTLE (53002-2350-7) 2019-01-010000-00-00NoNoCurrent
53002-2350-95300223500914 TABLET, FILM COATED in 1 BOTTLE (53002-2350-9) 2019-01-010000-00-00NoNoCurrent