FDA.reportPublic FDA data

Levofloxacin

Product NDC
70518-0968
11-digit product format
705180968
Labeler code
70518
Product ID
70518-0968_4b1a355c-3cdc-3f29-e063-6394a90a970a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202801
Marketing category
ANDA
Marketing start
2018-01-22
Substance
LEVOFLOXACIN
Active strength
750 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
LEVOFLOXACIN750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6GNT3Y5LMF
Rxcui311296

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
70518-0968-0Levofloxacin30 in 1 BLISTER PACKTABLET, FILM COATED3018
70518-0968-1Levofloxacin20 in 1 BLISTER PACKTABLET, FILM COATED2018
70518-0968-2Levofloxacin7 in 1 BOTTLE, PLASTICTABLET, FILM COATED718
70518-0968-3Levofloxacin5 in 1 BOTTLE, PLASTICTABLET, FILM COATED518

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0968LEVOFLOXACIN TABLET, FILM COATED [REMEDYREPACK INC.]14Current NDC, Legacy NDC, 4 package rows20250504_2a4e97e0-0709-411b-92e8-6f7d669412e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311296levoFLOXacin 750 MG Oral TabletPSN2a4e97e0-0709-411b-92e8-6f7d669412e418
311296levofloxacin 750 MG Oral TabletSCD2a4e97e0-0709-411b-92e8-6f7d669412e418

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-0968-07051809680030 TABLET, FILM COATED in 1 BLISTER PACK (70518-0968-0) 2018-01-220000-00-00NoNoCurrent
70518-0968-17051809680120 TABLET, FILM COATED in 1 BLISTER PACK (70518-0968-1) 2021-06-250000-00-00NoNoCurrent
70518-0968-2705180968027 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0968-2) 2022-05-090000-00-00NoNoCurrent
70518-0968-3705180968035 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0968-3) 2024-04-29NoNoCurrent