Levofloxacin

Product NDC
55648-547
11-digit product format
556480547
Labeler code
55648
Product ID
55648-547_48b9f69b-8df6-40da-b1ff-ba2965853fe8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET
Route
ORAL
Labeler
Wockhardt Limited
Application
ANDA090367
Marketing category
ANDA
Marketing start
2011-06-20
Marketing end
0000-00-00
Substance
LEVOFLOXACIN
Active strength
750 mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-547-01Levofloxacin20 in 1 BOTTLETABLET203
55648-547-02Levofloxacin50 in 1 BOTTLETABLET503
55648-547-03Levofloxacin100 in 1 BOTTLETABLET1003
55648-547-04Levofloxacin500 in 1 BOTTLETABLET5003
55648-547-05Levofloxacin100 in 1 CARTONTABLET1003
55648-547-05Levofloxacin10 in 1 BLISTER PACKTABLET103

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOFLOXACINACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN TABLET [WOCKHARDT LIMITED]3
LEVOFLOXACIN ANHYDROUSACTIVE MOIETYRIX4E89Y14LEVOFLOXACIN TABLET [WOCKHARDT LIMITED]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOFLOXACIN TABLET [WOCKHARDT LIMITED]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LEVOFLOXACIN TABLET [WOCKHARDT LIMITED]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVOFLOXACIN TABLET [WOCKHARDT LIMITED]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEVOFLOXACIN TABLET [WOCKHARDT LIMITED]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOFLOXACIN TABLET [WOCKHARDT LIMITED]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLEVOFLOXACIN TABLET [WOCKHARDT LIMITED]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLEVOFLOXACIN TABLET [WOCKHARDT LIMITED]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ELEVOFLOXACIN TABLET [WOCKHARDT LIMITED]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LEVOFLOXACIN TABLET [WOCKHARDT LIMITED]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVOFLOXACIN TABLET [WOCKHARDT LIMITED]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LEVOFLOXACIN TABLET [WOCKHARDT LIMITED]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVOFLOXACIN TABLET [WOCKHARDT LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-547LEVOFLOXACIN TABLET [WOCKHARDT LIMITED]3Legacy NDC, 6 package rows20121219_ec61dd9d-a016-4740-b9b8-20754e50be98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199884levoFLOXacin 250 MG Oral TabletPSNec61dd9d-a016-4740-b9b8-20754e50be983
199885levoFLOXacin 500 MG Oral TabletPSNec61dd9d-a016-4740-b9b8-20754e50be983
311296levoFLOXacin 750 MG Oral TabletPSNec61dd9d-a016-4740-b9b8-20754e50be983
199884levofloxacin 250 MG Oral TabletSCDec61dd9d-a016-4740-b9b8-20754e50be983
199885levofloxacin 500 MG Oral TabletSCDec61dd9d-a016-4740-b9b8-20754e50be983
311296levofloxacin 750 MG Oral TabletSCDec61dd9d-a016-4740-b9b8-20754e50be983
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSYec61dd9d-a016-4740-b9b8-20754e50be983

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-547-015564805470120 in 1 BOTTLEHistorical
55648-547-025564805470250 in 1 BOTTLEHistorical
55648-547-0355648054703100 in 1 BOTTLEHistorical
55648-547-0455648054704500 in 1 BOTTLEHistorical
55648-547-0555648054705100 in 1 CARTONHistorical