Levofloxacin

Product NDC
33342-021
11-digit product format
333420021
Labeler code
33342
Product ID
33342-021_6e18a5b5-0bd5-4d25-a845-c9f44ce0151d
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
Marketing end
0000-00-00
Substance
LEVOFLOXACIN
Active strength
250 mg/1
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-021-08EA - Each33342-0217cf49939-7cbc-42fd-a0f7-24261114195f12013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOFLOXACINACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
LEVOFLOXACIN ANHYDROUSACTIVE MOIETYRIX4E89Y14LEVOFLOXACIN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOFLOXACIN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLEVOFLOXACIN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LEVOFLOXACIN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVOFLOXACIN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEVOFLOXACIN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOFLOXACIN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALEVOFLOXACIN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLEVOFLOXACIN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVOFLOXACIN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]9
LEVOFLOXACINACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]3
LEVOFLOXACIN ANHYDROUSACTIVE MOIETYRIX4E89Y14LEVOFLOXACIN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOFLOXACIN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLEVOFLOXACIN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LEVOFLOXACIN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEVOFLOXACIN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOFLOXACIN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALEVOFLOXACIN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLEVOFLOXACIN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVOFLOXACIN TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-021LEVOFLOXACIN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]22Legacy NDC20230219_6ed56fa0-4813-4dc9-82c7-6dadf91f586f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199884levoFLOXacin 250 MG Oral TabletPSN4e018151-a169-2b32-e054-00144ff88e885
199884levofloxacin 250 MG Oral TabletSCD4e018151-a169-2b32-e054-00144ff88e885
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSY4e018151-a169-2b32-e054-00144ff88e885
211815LEVAQUIN 250 MG Oral TabletPSN33c4a32f-15f4-3d0c-e054-00144ff88e881
199884levoFLOXacin 250 MG Oral TabletPSN33c4a32f-15f4-3d0c-e054-00144ff88e881
199884levoFLOXacin 250 MG Oral TabletPSN75480aa3-0703-40bb-8fdf-12bc0d46d9731
211815levofloxacin 250 MG Oral Tablet [Levaquin]SBD33c4a32f-15f4-3d0c-e054-00144ff88e881
199884levofloxacin 250 MG Oral TabletSCD33c4a32f-15f4-3d0c-e054-00144ff88e881
199884levofloxacin 250 MG Oral TabletSCD75480aa3-0703-40bb-8fdf-12bc0d46d9731
211815Levaquin 250 MG Oral TabletSY33c4a32f-15f4-3d0c-e054-00144ff88e881
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSY33c4a32f-15f4-3d0c-e054-00144ff88e881
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSY75480aa3-0703-40bb-8fdf-12bc0d46d9731

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
33342-021-083334200210850 TABLET, FILM COATED in 1 BOTTLE (33342-021-08) 2012-03-220000-00-00NoNoCurrent
33342-021-1133342002111100 TABLET, FILM COATED in 1 BOTTLE (33342-021-11) 2012-03-220000-00-00NoNoCurrent
33342-021-1233342002112100 TABLET, FILM COATED in 1 BLISTER PACK (33342-021-12) 2012-03-220000-00-00NoNoCurrent
33342-021-313334200213150 TABLET, FILM COATED in 1 BLISTER PACK (33342-021-31) 2012-03-220000-00-00NoNoCurrent