LEVOFLOXACIN

Product NDC
58517-220
11-digit product format
585170220
Labeler code
58517
Product ID
58517-220_a13d2414-c7fe-4202-9cb4-a78984cb1fba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOFLOXACIN
Dosage form
TABLET
Route
ORAL
Labeler
New Horizon Rx Group, LLC
Application
ANDA090722
Marketing category
ANDA
Marketing start
2013-08-25
Marketing end
0000-00-00
Substance
LEVOFLOXACIN
Active strength
500 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
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
58517-220-20LEVOFLOXACIN20 in 1 BOTTLETABLET203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58517-220-20EA - Each58517-2204a501cf3-7262-4a84-b009-94f4298abf5d12013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOFLOXACINACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN TABLET [NEW HORIZON RX GROUP, LLC]3
LEVOFLOXACIN ANHYDROUSACTIVE MOIETYRIX4E89Y14LEVOFLOXACIN TABLET [NEW HORIZON RX GROUP, LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOFLOXACIN TABLET [NEW HORIZON RX GROUP, LLC]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLEVOFLOXACIN TABLET [NEW HORIZON RX GROUP, LLC]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LEVOFLOXACIN TABLET [NEW HORIZON RX GROUP, LLC]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVOFLOXACIN TABLET [NEW HORIZON RX GROUP, LLC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEVOFLOXACIN TABLET [NEW HORIZON RX GROUP, LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOFLOXACIN TABLET [NEW HORIZON RX GROUP, LLC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALEVOFLOXACIN TABLET [NEW HORIZON RX GROUP, LLC]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLEVOFLOXACIN TABLET [NEW HORIZON RX GROUP, LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVOFLOXACIN TABLET [NEW HORIZON RX GROUP, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58517-220LEVOFLOXACIN TABLET [NEW HORIZON RX GROUP, LLC]3Legacy NDC, 1 package rows20131231_cbcf5738-9a6a-4ff8-ab44-80cc587fa832.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199885levoFLOXacin 500 MG Oral TabletPSNcbcf5738-9a6a-4ff8-ab44-80cc587fa8323
199885levofloxacin 500 MG Oral TabletSCDcbcf5738-9a6a-4ff8-ab44-80cc587fa8323

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
58517-220-205851702202020 in 1 BOTTLEHistorical