FDA.reportPublic FDA data

LEVOFLOXACIN

Product NDC
61919-704
11-digit product format
619190704
Labeler code
61919
Product ID
61919-704_f2155472-cb0b-1bb5-e053-2a95a90a25dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOFLOXACIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA200839
Marketing category
ANDA
Marketing start
2019-08-29
Marketing end
0000-00-00
Substance
LEVOFLOXACIN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2024-12-31
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
61919-704-032025-01-30C16284748780-12cef2736-6cb7-d83d-e063-dadaa90ab31fLEVOFLOXACIN
61919-704-142025-01-30C16284748780-12cef2736-8d67-d83d-e063-dadaa90ab31fLEVOFLOXACIN
61919-704-072020-01-31C16284748780-19d75b9d0-21d6-f424-e053-dadaa90a57ceLEVOFLOXACIN
61919-704-102020-01-31C16284748780-19d75b9d0-21d6-f424-e053-dadaa90a57ceLEVOFLOXACIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-704-03LEVOFLOXACIN3 in 1 BOTTLETABLET, FILM COATED34
61919-704-14LEVOFLOXACIN14 in 1 BOTTLETABLET, FILM COATED143
61919-704-07LEVOFLOXACIN7 in 1 BOTTLETABLET, FILM COATED72
61919-704-10LEVOFLOXACIN10 in 1 BOTTLETABLET, FILM COATED102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-704-03EA - Each61919-704b6007016-bf2a-4ecf-aa33-b0047d95c61c12019-09-05
61919-704-07EA - Each61919-704df748384-70b6-4c7e-bf5a-226291544af612016-09-02
61919-704-10EA - Each61919-704cde1c896-6df6-4408-b612-1ba798379c1612016-09-02
61919-704-14EA - Each61919-70404e39441-446a-4f77-a22d-dafbcc43060812019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOFLOXACINACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN TABLET, FILM COATED [DIRECTRX]2
LEVOFLOXACIN ANHYDROUSACTIVE MOIETYRIX4E89Y14LEVOFLOXACIN TABLET, FILM COATED [DIRECTRX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOFLOXACIN TABLET, FILM COATED [DIRECTRX]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLEVOFLOXACIN TABLET, FILM COATED [DIRECTRX]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LEVOFLOXACIN TABLET, FILM COATED [DIRECTRX]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVOFLOXACIN TABLET, FILM COATED [DIRECTRX]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEVOFLOXACIN TABLET, FILM COATED [DIRECTRX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOFLOXACIN TABLET, FILM COATED [DIRECTRX]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALEVOFLOXACIN TABLET, FILM COATED [DIRECTRX]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLEVOFLOXACIN TABLET, FILM COATED [DIRECTRX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVOFLOXACIN TABLET, FILM COATED [DIRECTRX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-704LEVOFLOXACIN TABLET, FILM COATED [DIRECT_RX]4Legacy NDC, 1 package rows20230113_9147184f-2434-11f4-e053-2a95a90aec86.zip
61919-704LEVOFLOXACIN TABLET, FILM COATED [DIRECT_RX]3Legacy NDC, 1 package rows20230113_91470944-ffe8-6377-e053-2a95a90afa0e.zip
61919-704LEVOFLOXACIN TABLET, FILM COATED [DIRECTRX]2Legacy NDC, 2 package rows20151029_9b5d0c51-9118-4f12-b9d7-03196236db20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199885levoFLOXacin 500 MG Oral TabletPSN9147184f-2434-11f4-e053-2a95a90aec864
199885levofloxacin 500 MG Oral TabletSCD9147184f-2434-11f4-e053-2a95a90aec864
199885levoFLOXacin 500 MG Oral TabletPSN91470944-ffe8-6377-e053-2a95a90afa0e3
199885levofloxacin 500 MG Oral TabletSCD91470944-ffe8-6377-e053-2a95a90afa0e3
199885levoFLOXacin 500 MG Oral TabletPSN9b5d0c51-9118-4f12-b9d7-03196236db202
199885levofloxacin 500 MG Oral TabletSCD9b5d0c51-9118-4f12-b9d7-03196236db202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-704-03619190704033 TABLET, FILM COATED in 1 BOTTLE (61919-704-03) 2019-08-290000-00-00NoNoCurrent
61919-704-07619190704077 in 1 BOTTLEHistorical
61919-704-106191907041010 in 1 BOTTLEHistorical
61919-704-146191907041414 TABLET, FILM COATED in 1 BOTTLE (61919-704-14) 2019-08-290000-00-00NoNoCurrent