FDA.reportPublic FDA data

levofloxacin

Product NDC
67296-2242
11-digit product format
672962242
Labeler code
67296
Product ID
67296-2242_5261da1d-6bde-7088-e063-6294a90a83dc
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
250 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
LEVOFLOXACIN250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6GNT3Y5LMF
Rxcui199884

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
67296-2242-3levofloxacin5 in 1 BOTTLETABLET, FILM COATED51

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199884levoFLOXacin 250 MG Oral TabletPSN5261da15-1b6c-fbe2-e063-6394a90ad85e1
199884levofloxacin 250 MG Oral TabletSCD5261da15-1b6c-fbe2-e063-6394a90ad85e1
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSY5261da15-1b6c-fbe2-e063-6394a90ad85e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67296-2242-3672962242035 TABLET, FILM COATED in 1 BOTTLE (67296-2242-3) 2022-01-10YesNoHistorical