FDA.reportPublic FDA data

Levofloxacin

Product NDC
70518-0453
11-digit product format
705180453
Labeler code
70518
Product ID
70518-0453_47f6f2fe-c984-3c24-e063-6294a90ac1cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076710
Marketing category
ANDA
Marketing start
2017-04-21
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

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
70518-0453-0Levofloxacin7 in 1 BOTTLE, PLASTICTABLET, FILM COATED721
70518-0453-1Levofloxacin10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1021
70518-0453-2Levofloxacin30 in 1 BLISTER PACKTABLET, FILM COATED3021
70518-0453-3Levofloxacin30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0453LEVOFLOXACIN TABLET, FILM COATED [REMEDYREPACK INC.]16Current NDC, Legacy NDC, 4 package rows20250427_f14cf651-a213-4a4f-adb9-f628562af27c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199885levoFLOXacin 500 MG Oral TabletPSNf14cf651-a213-4a4f-adb9-f628562af27c21
199885levofloxacin 500 MG Oral TabletSCDf14cf651-a213-4a4f-adb9-f628562af27c21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-0453-0705180453007 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0453-0) 2017-04-210000-00-00NoNoCurrent
70518-0453-17051804530110 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0453-1) 2018-04-130000-00-00NoNoCurrent
70518-0453-27051804530230 TABLET, FILM COATED in 1 BLISTER PACK (70518-0453-2) 2019-12-190000-00-00NoNoCurrent
70518-0453-37051804530330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0453-3) 2024-05-13NoNoHistorical