FDA.reportPublic FDA data

Levofloxacin

Product NDC
61919-741
11-digit product format
619190741
Labeler code
61919
Product ID
61919-741_b89d05de-feee-4ce7-8edd-4dd1bdf8ee9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Application
ANDA200839
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
61919-741-052020-01-31C16284748780-19d75b9d1-0393-f424-e053-dadaa90a57ceLevofloxacin
61919-741-102020-01-31C16284748780-19d75b9d1-0393-f424-e053-dadaa90a57ceLevofloxacin
61919-741-142020-01-31C16284748780-19d75b9d1-0393-f424-e053-dadaa90a57ceLevofloxacin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-741-05Levofloxacin5 in 1 BOTTLETABLET52
61919-741-10Levofloxacin10 in 1 BOTTLETABLET102
61919-741-14Levofloxacin14 in 1 BOTTLETABLET142

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-741-05EA - Each61919-74147f8688b-d1d3-47f7-be3e-afe38dd8244512016-09-02
61919-741-10EA - Each61919-7412d826b01-e2c8-4cc9-9300-f862b463974012016-09-02
61919-741-14EA - Each61919-7412957a4ed-95af-4a57-8a79-69a5dc20134912016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOFLOXACINACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN TABLET [DIRECT RX]2
LEVOFLOXACIN ANHYDROUSACTIVE MOIETYRIX4E89Y14LEVOFLOXACIN TABLET [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOFLOXACIN TABLET [DIRECT RX]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLEVOFLOXACIN TABLET [DIRECT RX]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEVOFLOXACIN TABLET [DIRECT RX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOFLOXACIN TABLET [DIRECT RX]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALEVOFLOXACIN TABLET [DIRECT RX]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLEVOFLOXACIN TABLET [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVOFLOXACIN TABLET [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-741LEVOFLOXACIN TABLET [DIRECT RX]2Legacy NDC, 3 package rows20151111_593f7324-6cc4-4259-b4e5-6952be31a7bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311296levoFLOXacin 750 MG Oral TabletPSN593f7324-6cc4-4259-b4e5-6952be31a7bd2
311296levofloxacin 750 MG Oral TabletSCD593f7324-6cc4-4259-b4e5-6952be31a7bd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-741-05619190741055 in 1 BOTTLEHistorical
61919-741-106191907411010 in 1 BOTTLEHistorical
61919-741-146191907411414 in 1 BOTTLEHistorical