FDA.reportPublic FDA data

Levofloxacin

Product NDC
55111-279
11-digit product format
551110279
Labeler code
55111
Product ID
55111-279_c51f53eb-2f01-93dc-e7e6-695b20b639ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA076710
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
55111-279-01Levofloxacin100 in 1 BOTTLETABLET, FILM COATED10021
55111-279-05Levofloxacin500 in 1 BOTTLETABLET, FILM COATED50021
55111-279-30Levofloxacin30 in 1 BOTTLETABLET, FILM COATED3021
55111-279-50Levofloxacin50 in 1 BOTTLETABLET, FILM COATED5021
55111-279-78Levofloxacin10 in 1 CARTONTABLET, FILM COATED1021
55111-279-79Levofloxacin10 in 1 BLISTER PACKTABLET, FILM COATED1021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-279-50EA - Each55111-279ee7bd303-60e5-4823-bbd8-d7a8adf3043212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LevofloxacinACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]9
LEVOFLOXACIN ANHYDROUSACTIVE MOIETYRIX4E89Y14LEVOFLOXACIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOFLOXACIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]9
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4LEVOFLOXACIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]9
crospovidoneINACTIVE INGREDIENT68401960MKLEVOFLOXACIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]9
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MLEVOFLOXACIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]9
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVOFLOXACIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]9
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVOFLOXACIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEVOFLOXACIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]9
magnesium stearateINACTIVE INGREDIENT70097M6I30LEVOFLOXACIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]9
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALEVOFLOXACIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVOFLOXACIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]9
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLEVOFLOXACIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]9
LevofloxacinACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
LevofloxacinACTIVE MOIETY6GNT3Y5LMFLEVOFLOXACIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOFLOXACIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4LEVOFLOXACIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
crospovidoneINACTIVE INGREDIENT68401960MKLEVOFLOXACIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MLEVOFLOXACIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVOFLOXACIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVOFLOXACIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEVOFLOXACIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
magnesium stearateINACTIVE INGREDIENT70097M6I30LEVOFLOXACIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ALEVOFLOXACIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVOFLOXACIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLEVOFLOXACIN TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]5
LEVOFLOXACINACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
LEVOFLOXACIN ANHYDROUSACTIVE MOIETYRIX4E89Y14LEVOFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLEVOFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MLEVOFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LEVOFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVOFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEVOFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALEVOFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVOFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLEVOFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVOFLOXACIN TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-279LEVOFLOXACIN TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED ]21Current NDC, Legacy NDC, 6 package rows20240806_9b59428a-a23a-b2d9-982f-98f8a1ed381f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199884levoFLOXacin 250 MG Oral TabletPSN9b59428a-a23a-b2d9-982f-98f8a1ed381f21
199885levoFLOXacin 500 MG Oral TabletPSN9b59428a-a23a-b2d9-982f-98f8a1ed381f21
311296levoFLOXacin 750 MG Oral TabletPSN9b59428a-a23a-b2d9-982f-98f8a1ed381f21
199884levofloxacin 250 MG Oral TabletSCD9b59428a-a23a-b2d9-982f-98f8a1ed381f21
199885levofloxacin 500 MG Oral TabletSCD9b59428a-a23a-b2d9-982f-98f8a1ed381f21
311296levofloxacin 750 MG Oral TabletSCD9b59428a-a23a-b2d9-982f-98f8a1ed381f21
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSY9b59428a-a23a-b2d9-982f-98f8a1ed381f21
199884levoFLOXacin 250 MG Oral TabletPSNac4001ca-882f-4d9b-a570-c1b9d7fd68306
199885levoFLOXacin 500 MG Oral TabletPSNac4001ca-882f-4d9b-a570-c1b9d7fd68306
311296levoFLOXacin 750 MG Oral TabletPSNac4001ca-882f-4d9b-a570-c1b9d7fd68306
199884levofloxacin 250 MG Oral TabletSCDac4001ca-882f-4d9b-a570-c1b9d7fd68306
199885levofloxacin 500 MG Oral TabletSCDac4001ca-882f-4d9b-a570-c1b9d7fd68306
311296levofloxacin 750 MG Oral TabletSCDac4001ca-882f-4d9b-a570-c1b9d7fd68306
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSYac4001ca-882f-4d9b-a570-c1b9d7fd68306
199884levoFLOXacin 250 MG Oral TabletPSNbfe280be-0789-69fa-e053-2a95a90a0e135
199884levoFLOXacin 250 MG Oral TabletPSN2e88afd5-a9f3-4790-8945-80e12bdd49565
199885levoFLOXacin 500 MG Oral TabletPSNbfe280be-0789-69fa-e053-2a95a90a0e135
199885levoFLOXacin 500 MG Oral TabletPSN2e88afd5-a9f3-4790-8945-80e12bdd49565
311296levoFLOXacin 750 MG Oral TabletPSNbfe280be-0789-69fa-e053-2a95a90a0e135
311296levoFLOXacin 750 MG Oral TabletPSN2e88afd5-a9f3-4790-8945-80e12bdd49565
199884levofloxacin 250 MG Oral TabletSCDbfe280be-0789-69fa-e053-2a95a90a0e135
199884levofloxacin 250 MG Oral TabletSCD2e88afd5-a9f3-4790-8945-80e12bdd49565
199885levofloxacin 500 MG Oral TabletSCD2e88afd5-a9f3-4790-8945-80e12bdd49565
199885levofloxacin 500 MG Oral TabletSCDbfe280be-0789-69fa-e053-2a95a90a0e135
311296levofloxacin 750 MG Oral TabletSCDbfe280be-0789-69fa-e053-2a95a90a0e135
311296levofloxacin 750 MG Oral TabletSCD2e88afd5-a9f3-4790-8945-80e12bdd49565
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSY2e88afd5-a9f3-4790-8945-80e12bdd49565
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSYbfe280be-0789-69fa-e053-2a95a90a0e135
199884levoFLOXacin 250 MG Oral TabletPSN50224ecd-8872-177e-e054-00144ff88e884
199884levofloxacin 250 MG Oral TabletSCD50224ecd-8872-177e-e054-00144ff88e884
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSY50224ecd-8872-177e-e054-00144ff88e884
199884levoFLOXacin 250 MG Oral TabletPSNf780bb91-483a-d1a6-e053-6294a90ab74b2
199884levofloxacin 250 MG Oral TabletSCDf780bb91-483a-d1a6-e053-6294a90ab74b2
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSYf780bb91-483a-d1a6-e053-6294a90ab74b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-279-0155111027901100 TABLET, FILM COATED in 1 BOTTLE (55111-279-01) 2011-06-200000-00-00NoNoCurrent
55111-279-0555111027905500 TABLET, FILM COATED in 1 BOTTLE (55111-279-05) 2011-06-200000-00-00NoNoCurrent
55111-279-305511102793030 TABLET, FILM COATED in 1 BOTTLE (55111-279-30) 2011-06-200000-00-00NoNoCurrent
55111-279-505511102795050 TABLET, FILM COATED in 1 BOTTLE (55111-279-50) 2011-06-200000-00-00NoNoCurrent
55111-279-785511102797810 BLISTER PACK in 1 CARTON (55111-279-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-279-79) 10 blister pack2011-06-200000-00-00NoNoCurrent
55111-279-795511102797910 in 1 BLISTER PACKHistorical