FDA.reportPublic FDA data

Levofloxacin

Product NDC
68180-241
11-digit product format
681800241
Labeler code
68180
Product ID
68180-241_04b864a6-b2f7-4e3d-aa12-32a501054b9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA078424
Marketing category
ANDA
Marketing start
2011-06-20
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
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
68180-241-01Levofloxacin100 in 1 BOTTLETABLET, FILM COATED10025
68180-241-02Levofloxacin500 in 1 BOTTLETABLET, FILM COATED50025
68180-241-08Levofloxacin50 in 1 BOTTLETABLET, FILM COATED5025
68180-241-11Levofloxacin10 in 1 BLISTER PACKTABLET, FILM COATED1025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-241-01EA - Each68180-24126eb2d85-e462-4629-8160-733a32bdb18b12012-07-24
68180-241-02EA - Each68180-241954d6783-d1fb-4b92-8c67-c1d305e8bda412012-07-24
68180-241-08EA - Each68180-24115851e4b-5858-46d9-961b-3d8a9e4d129812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOFLOXACINACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
LEVOFLOXACIN ANHYDROUSACTIVE MOIETYRIX4E89Y14LEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4LEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
SHELLACINACTIVE INGREDIENT46N107B71OLEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-241LEVOFLOXACIN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]25Current NDC, Legacy NDC, 4 package rows20240716_4be13bd5-0c39-43c3-9232-b1226ccd4dbc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199884levoFLOXacin 250 MG Oral TabletPSN4be13bd5-0c39-43c3-9232-b1226ccd4dbc25
199885levoFLOXacin 500 MG Oral TabletPSN4be13bd5-0c39-43c3-9232-b1226ccd4dbc25
311296levoFLOXacin 750 MG Oral TabletPSN4be13bd5-0c39-43c3-9232-b1226ccd4dbc25
199884levofloxacin 250 MG Oral TabletSCD4be13bd5-0c39-43c3-9232-b1226ccd4dbc25
199885levofloxacin 500 MG Oral TabletSCD4be13bd5-0c39-43c3-9232-b1226ccd4dbc25
311296levofloxacin 750 MG Oral TabletSCD4be13bd5-0c39-43c3-9232-b1226ccd4dbc25
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSY4be13bd5-0c39-43c3-9232-b1226ccd4dbc25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-241-0168180024101100 TABLET, FILM COATED in 1 BOTTLE (68180-241-01) 2011-06-200000-00-00NoNoCurrent
68180-241-0268180024102500 TABLET, FILM COATED in 1 BOTTLE (68180-241-02) 2011-06-200000-00-00NoNoCurrent
68180-241-086818002410850 TABLET, FILM COATED in 1 BOTTLE (68180-241-08) 2011-06-200000-00-00NoNoCurrent
68180-241-116818002411110 in 1 BLISTER PACKHistorical
68180-241-136818002411310 BLISTER PACK in 1 CARTON (68180-241-13) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68180-241-11) 10 blister pack2011-06-200000-00-00NoNoCurrent