FDA.reportPublic FDA data

Levofloxacin

Product NDC
70518-3712
11-digit product format
705183712
Labeler code
70518
Product ID
70518-3712_51393c87-8b73-0f84-e063-6294a90af339
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA201043
Marketing category
ANDA
Marketing start
2023-04-12
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
70518-3712-0Levofloxacin10 in 1 BOTTLE, PLASTICTABLET, FILM COATED106
70518-3712-1Levofloxacin7 in 1 BOTTLE, PLASTICTABLET, FILM COATED76
70518-3712-2Levofloxacin30 in 1 BOTTLE, PLASTICTABLET, FILM COATED306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3712LEVOFLOXACIN TABLET, FILM COATED [REMEDYREPACK INC.]4Current NDC, 3 package rows20241017_9f944b63-9b60-437a-ba57-d14d7976bc32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199885levoFLOXacin 500 MG Oral TabletPSN9f944b63-9b60-437a-ba57-d14d7976bc326
199885levofloxacin 500 MG Oral TabletSCD9f944b63-9b60-437a-ba57-d14d7976bc326

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-3712-07051837120010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3712-0) 2023-04-12NoNoHistorical
70518-3712-1705183712017 in 1 BOTTLE, PLASTICHistorical
70518-3712-27051837120230 in 1 BOTTLE, PLASTICHistorical