FDA.reportPublic FDA data

levofloxacin

Product NDC
67296-2126
11-digit product format
672962126
Labeler code
67296
Product ID
67296-2126_4698b375-8426-5908-e063-6394a90ab03e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Redpharm Drug
Application
ANDA077652
Marketing category
ANDA
Marketing start
2022-01-10
Substance
LEVOFLOXACIN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
levofloxacin
Listing expiration
2026-12-31

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
67296-2126-1levofloxacin10 in 1 BOTTLETABLET, FILM COATED107
67296-2126-5levofloxacin5 in 1 BOTTLETABLET, FILM COATED57
67296-2126-7levofloxacin7 in 1 BOTTLETABLET, FILM COATED77

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-2126LEVOFLOXACIN TABLET, FILM COATED [REDPHARM DRUG]4Current NDC, 3 package rows20250410_301ecffc-ecaf-01de-e063-6294a90a61b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199885levoFLOXacin 500 MG Oral TabletPSN301ecffc-ecaf-01de-e063-6294a90a61b37
199885levofloxacin 500 MG Oral TabletSCD301ecffc-ecaf-01de-e063-6294a90a61b37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67296-2126-16729621260110 TABLET, FILM COATED in 1 BOTTLE (67296-2126-1) 2022-01-10NoNoCurrent
67296-2126-5672962126055 TABLET, FILM COATED in 1 BOTTLE (67296-2126-5) 2022-01-10YesNoCurrent
67296-2126-7672962126077 TABLET, FILM COATED in 1 BOTTLE (67296-2126-7) 2022-01-10NoNoCurrent