FDA.reportPublic FDA data

Levofloxacin

Product NDC
33342-531
11-digit product format
333420531
Labeler code
33342
Product ID
33342-531_fc165a6d-24b0-4753-a7ac-94a134dca0d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA200839
Marketing category
ANDA
Marketing start
2012-03-22
Substance
LEVOFLOXACIN
Active strength
250 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
LEVOFLOXACIN250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6GNT3Y5LMF
Rxcui199884, 199885, 311296

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
33342-531-08Levofloxacin50 in 1 BOTTLETABLET, FILM COATED501
33342-531-11Levofloxacin100 in 1 BOTTLETABLET, FILM COATED1001
33342-531-12Levofloxacin100 in 1 BLISTER PACKTABLET, FILM COATED1001
33342-531-31Levofloxacin50 in 1 BLISTER PACKTABLET, FILM COATED501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-531-08EA - Each33342-531ba210cc5-72ab-46a2-8910-ea47b949430312023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-531LEVOFLOXACIN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]1Current NDC, Legacy NDC, 4 package rows20230110_fc165a6d-24b0-4753-a7ac-94a134dca0d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199884levoFLOXacin 250 MG Oral TabletPSNfc165a6d-24b0-4753-a7ac-94a134dca0d31
199885levoFLOXacin 500 MG Oral TabletPSNfc165a6d-24b0-4753-a7ac-94a134dca0d31
311296levoFLOXacin 750 MG Oral TabletPSNfc165a6d-24b0-4753-a7ac-94a134dca0d31
199884levofloxacin 250 MG Oral TabletSCDfc165a6d-24b0-4753-a7ac-94a134dca0d31
199885levofloxacin 500 MG Oral TabletSCDfc165a6d-24b0-4753-a7ac-94a134dca0d31
311296levofloxacin 750 MG Oral TabletSCDfc165a6d-24b0-4753-a7ac-94a134dca0d31
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSYfc165a6d-24b0-4753-a7ac-94a134dca0d31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
33342-531-083334205310850 TABLET, FILM COATED in 1 BOTTLE (33342-531-08) 2012-03-220000-00-00NoNoCurrent
33342-531-1133342053111100 TABLET, FILM COATED in 1 BOTTLE (33342-531-11) 2012-03-220000-00-00NoNoCurrent
33342-531-1233342053112100 TABLET, FILM COATED in 1 BLISTER PACK (33342-531-12) 2012-03-220000-00-00NoNoCurrent
33342-531-313334205313150 TABLET, FILM COATED in 1 BLISTER PACK (33342-531-31) 2012-03-220000-00-00NoNoCurrent