Levofloxacin

Product NDC
63187-003
11-digit product format
631870003
Labeler code
63187
Product ID
63187-003_d3c398d7-5370-40dc-bbe2-8621026bec3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx
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
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63187-003-102019-12-10C16284748780-19855e2a2-3807-60a7-e053-dbdaa90a05bd110b351c-fd13-408a-bf08-e47c1fcd8c93
63187-003-102019-11-27C16284748780-19855e2a2-3807-60a7-e053-dbdaa90a05bd110b351c-fd13-408a-bf08-e47c1fcd8c93

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-003-10EA - Each63187-0037e119f3f-9b42-4882-b882-be643602ab5512016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOFLOXACINACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]1
LEVOFLOXACIN ANHYDROUSACTIVE MOIETYRIX4E89Y14LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]1
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PLEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]1
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WLEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XLEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-003LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX]2Legacy NDC20191210_110b351c-fd13-408a-bf08-e47c1fcd8c93.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-003-106318700031010 TABLET, FILM COATED in 1 BOTTLE (63187-003-10) 2014-05-010000-00-00NoNoCurrent