LEVOFLOXACIN

Product NDC
61919-987
11-digit product format
619190987
Labeler code
61919
Product ID
61919-987_9c977ee6-6a36-8e66-e053-2995a90af0fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOFLOXACIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA201043
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
LEVOFLOXACIN
Active strength
250 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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
61919-987-102023-01-30C16284748780-1f386c64a-2022-0266-e053-dadaa90a7c1aLEVOFLOXACIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-987-10LEVOFLOXACIN10 in 1 BOTTLETABLET, FILM COATED103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-987-10EA - Each61919-9878672c0b3-a590-4afa-8751-b396b9e26d5512015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOFLOXACINACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]1
LEVOFLOXACIN ANHYDROUSACTIVE MOIETYRIX4E89Y14LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-987LEVOFLOXACIN TABLET, FILM COATED [DIRECT RX]3Legacy NDC, 1 package rows20200121_9bbff94f-3f0e-47ec-bf4c-79de77c0688f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199884levoFLOXacin 250 MG Oral TabletPSN9bbff94f-3f0e-47ec-bf4c-79de77c0688f3
199884levofloxacin 250 MG Oral TabletSCD9bbff94f-3f0e-47ec-bf4c-79de77c0688f3
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSY9bbff94f-3f0e-47ec-bf4c-79de77c0688f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-987-106191909871010 TABLET, FILM COATED in 1 BOTTLE (61919-987-10) 2014-01-010000-00-00NoNoCurrent