FDA.reportPublic FDA data

Levofloxacin

Product NDC
50436-6585
11-digit product format
504366585
Labeler code
50436
Product ID
50436-6585_c98cbc80-6a06-4c04-956c-fc90661787f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA077438
Marketing category
ANDA
Marketing start
2011-06-20
Marketing end
0000-00-00
Substance
LEVOFLOXACIN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-6585-12020-01-31C16284748780-19d75b9d0-3334-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996
50436-6585-22020-01-31C16284748780-19d75b9d0-3334-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-6585-1Levofloxacin10 in 1 BOTTLETABLET, FILM COATED104
50436-6585-2Levofloxacin7 in 1 BOTTLETABLET, FILM COATED74

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-6585-1EA - Each50436-6585a8c3d760-a3ff-48da-a612-120ff668b93d12014-12-01
50436-6585-2EA - Each50436-6585740aad77-6253-4249-9b67-e2713bf04fcf12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOFLOXACINACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
LEVOFLOXACINACTIVE MOIETY6GNT3Y5LMFLEVOFLOXACIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEVOFLOXACIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVOFLOXACIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
GLYCEROL 1,2-DIDOCOSANOATEINACTIVE INGREDIENT21E45121YSLEVOFLOXACIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PLEVOFLOXACIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WLEVOFLOXACIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLEVOFLOXACIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLEVOFLOXACIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XLEVOFLOXACIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVOFLOXACIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LEVOFLOXACIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVOFLOXACIN TABLET, FILM COATED [UNIT DOSE SERVICES]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVOFLOXACIN TABLET, FILM COATED [UNIT DOSE SERVICES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-6585LEVOFLOXACIN TABLET, FILM COATED [UNIT DOSE SERVICES]4Legacy NDC, 2 package rows20170718_1fa2c0d2-f22d-4f63-89c3-26e0a4216bfc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199885levoFLOXacin 500 MG Oral TabletPSN1fa2c0d2-f22d-4f63-89c3-26e0a4216bfc4
199885levofloxacin 500 MG Oral TabletSCD1fa2c0d2-f22d-4f63-89c3-26e0a4216bfc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-6585-15043665850110 in 1 BOTTLEHistorical
50436-6585-2504366585027 in 1 BOTTLEHistorical