FDA.reportPublic FDA data

Levofloxacin

Product NDC
70518-0587
11-digit product format
705180587
Labeler code
70518
Product ID
70518-0587_47f9f533-257a-b04a-e063-6394a90a946b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202801
Marketing category
ANDA
Marketing start
2017-06-26
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
70518-0587-0Levofloxacin30 in 1 BLISTER PACKTABLET, FILM COATED3021
70518-0587-1Levofloxacin10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1021
70518-0587-2Levofloxacin7 in 1 BOTTLE, PLASTICTABLET, FILM COATED721
70518-0587-3Levofloxacin7 in 1 BLISTER PACKTABLET, FILM COATED721
70518-0587-4Levofloxacin30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0587LEVOFLOXACIN TABLET, FILM COATED [REMEDYREPACK INC.]19Current NDC, Legacy NDC, 5 package rows20250507_16d51c1c-4144-4be7-9356-98fcee621ecd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199885levoFLOXacin 500 MG Oral TabletPSN16d51c1c-4144-4be7-9356-98fcee621ecd21
199885levofloxacin 500 MG Oral TabletSCD16d51c1c-4144-4be7-9356-98fcee621ecd21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-0587-07051805870030 TABLET, FILM COATED in 1 BLISTER PACK (70518-0587-0) 2017-06-260000-00-00NoNoCurrent
70518-0587-17051805870110 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0587-1) 2019-04-170000-00-00NoNoCurrent
70518-0587-2705180587027 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0587-2) 2019-05-290000-00-00NoNoCurrent
70518-0587-3705180587037 TABLET, FILM COATED in 1 BLISTER PACK (70518-0587-3) 2023-07-29NoNoCurrent
70518-0587-47051805870430 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0587-4) 2025-01-13NoNoCurrent