Levofloxacin

Product NDC
61919-867
11-digit product format
619190867
Labeler code
61919
Product ID
61919-867_286c9e47-6665-42ae-8fb5-e7dfa1b4703d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct RX
Application
ANDA076361
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
LEVOFLOXACIN
Active strength
750 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-867-142020-01-31C16284748780-19d75b9cf-f5f3-f424-e053-dadaa90a57ceLEVOFLOXACIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-867-07Levofloxacin7 in 1 BOTTLETABLET, FILM COATED73
61919-867-10Levofloxacin10 in 1 BOTTLETABLET, FILM COATED103
61919-867-14Levofloxacin14 in 1 BOTTLETABLET, FILM COATED143

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-867-07EA - Each61919-867fe0168eb-c68f-4664-b103-74fb70e90ca112014-05-02
61919-867-10EA - Each61919-86720dade34-3542-4c35-a796-586ce1f08bfc12014-05-02
61919-867-14EA - Each61919-867f85a9d43-0c66-4e46-8cc6-a41563a4571a12014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOFLOXACINACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
LEVOFLOXACIN ANHYDROUSACTIVE MOIETYRIX4E89Y14LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PLEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-867LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3Legacy NDC, 3 package rows20150807_6f38551b-7223-4e6d-8977-1c168dba1d06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199885levoFLOXacin 500 MG Oral TabletPSN6f38551b-7223-4e6d-8977-1c168dba1d063
311296levoFLOXacin 750 MG Oral TabletPSN6f38551b-7223-4e6d-8977-1c168dba1d063
199885levofloxacin 500 MG Oral TabletSCD6f38551b-7223-4e6d-8977-1c168dba1d063
311296levofloxacin 750 MG Oral TabletSCD6f38551b-7223-4e6d-8977-1c168dba1d063

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-867-07619190867077 in 1 BOTTLEHistorical
61919-867-106191908671010 in 1 BOTTLEHistorical
61919-867-146191908671414 in 1 BOTTLEHistorical