Levofloxacin

Product NDC
0781-5791
11-digit product format
007815791
Labeler code
0781
Product ID
0781-5791_f03e9691-8fbe-4175-bc2e-5c627895bb71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
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
2023-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5791-01EA - Each0781-5791733a59f6-ec1e-4cff-aafe-e8c6e58d95be12012-07-24
0781-5791-50EA - Each0781-57917cd7d1d5-0622-4563-8af9-f45bb3efbdf812012-07-24

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 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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-5791-0100781579101100 TABLET, FILM COATED in 1 BOTTLE (0781-5791-01) 2011-06-200000-00-00NoNoCurrent
0781-5791-10007815791101000 TABLET, FILM COATED in 1 BOTTLE (0781-5791-10) 2011-06-200000-00-00NoNoCurrent
0781-5791-500078157915050 TABLET, FILM COATED in 1 BOTTLE (0781-5791-50) 2011-06-200000-00-00NoNoCurrent