FDA.reportPublic FDA data

Levofloxacin

Product NDC
65862-536
11-digit product format
658620536
Labeler code
65862
Product ID
65862-536_00620274-6cae-4cb8-bd5d-8f80732ae3ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA201043
Marketing category
ANDA
Marketing start
2011-06-20
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
65862-536-10Levofloxacin10 in 1 BLISTER PACKTABLET, FILM COATED1023
65862-536-10Levofloxacin10 in 1 CARTONTABLET, FILM COATED1023
65862-536-50Levofloxacin50 in 1 BOTTLETABLET, FILM COATED5023
65862-536-99Levofloxacin1000 in 1 BOTTLETABLET, FILM COATED100023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-536-50EA - Each65862-53601b5f90f-8c87-4af6-b210-180fd41ceaf512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOFLOXACINACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
LEVOFLOXACIN ANHYDROUSACTIVE MOIETYRIX4E89Y14LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
LEVOFLOXACINACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]1
LEVOFLOXACIN ANHYDROUSACTIVE MOIETYRIX4E89Y14LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-536LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]23Current NDC, Legacy NDC, 4 package rows20240630_529ac72c-c4a0-4001-8cf9-b94f5bf7265c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199884levoFLOXacin 250 MG Oral TabletPSN529ac72c-c4a0-4001-8cf9-b94f5bf7265c23
199885levoFLOXacin 500 MG Oral TabletPSN529ac72c-c4a0-4001-8cf9-b94f5bf7265c23
311296levoFLOXacin 750 MG Oral TabletPSN529ac72c-c4a0-4001-8cf9-b94f5bf7265c23
199884levofloxacin 250 MG Oral TabletSCD529ac72c-c4a0-4001-8cf9-b94f5bf7265c23
199885levofloxacin 500 MG Oral TabletSCD529ac72c-c4a0-4001-8cf9-b94f5bf7265c23
311296levofloxacin 750 MG Oral TabletSCD529ac72c-c4a0-4001-8cf9-b94f5bf7265c23
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSY529ac72c-c4a0-4001-8cf9-b94f5bf7265c23
199884levoFLOXacin 250 MG Oral TabletPSN9bbff94f-3f0e-47ec-bf4c-79de77c0688f3
199884levoFLOXacin 250 MG Oral TabletPSN30958610-3803-45e6-aa3c-d256decbe6e43
199884levofloxacin 250 MG Oral TabletSCD9bbff94f-3f0e-47ec-bf4c-79de77c0688f3
199884levofloxacin 250 MG Oral TabletSCD30958610-3803-45e6-aa3c-d256decbe6e43
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSY30958610-3803-45e6-aa3c-d256decbe6e43
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSY9bbff94f-3f0e-47ec-bf4c-79de77c0688f3
199884levoFLOXacin 250 MG Oral TabletPSN2e32a8aa-047b-46c6-b67b-d88a9a0a810b1
199885levoFLOXacin 500 MG Oral TabletPSN2e32a8aa-047b-46c6-b67b-d88a9a0a810b1
311296levoFLOXacin 750 MG Oral TabletPSN2e32a8aa-047b-46c6-b67b-d88a9a0a810b1
199884levofloxacin 250 MG Oral TabletSCD2e32a8aa-047b-46c6-b67b-d88a9a0a810b1
199885levofloxacin 500 MG Oral TabletSCD2e32a8aa-047b-46c6-b67b-d88a9a0a810b1
311296levofloxacin 750 MG Oral TabletSCD2e32a8aa-047b-46c6-b67b-d88a9a0a810b1
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSY2e32a8aa-047b-46c6-b67b-d88a9a0a810b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-536-106586205361010 BLISTER PACK in 1 CARTON (65862-536-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2011-06-200000-00-00NoNoCurrent
65862-536-22658620536222000 TABLET, FILM COATED in 1 BAG (65862-536-22)20-JUN-11Current
65862-536-506586205365050 TABLET, FILM COATED in 1 BOTTLE (65862-536-50) 2011-06-200000-00-00NoNoCurrent
65862-536-606586205366060000 TABLET, FILM COATED in 1 BAG (65862-536-60)07-JAN-22Current
65862-536-99658620536991000 TABLET, FILM COATED in 1 BOTTLE (65862-536-99) 2011-06-200000-00-00NoNoCurrent