FDA.reportPublic FDA data

levofloxacin

Product NDC
10544-451
11-digit product format
105440451
Labeler code
10544
Product ID
10544-451_0c78fe35-97dd-4d37-be95-27ed6c14e312
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA077652
Marketing category
ANDA
Marketing start
2015-07-15
Marketing end
0000-00-00
Substance
LEVOFLOXACIN
Active strength
500 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
10544-451-102020-01-31C16284748780-19d75b9d1-2934-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use levofloxacin tablets safely and effectively. See full prescribing information for levofloxacin tablets. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-451-10levofloxacin10 in 1 BOTTLETABLET, FILM COATED108

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOFLOXACINACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]8
LEVOFLOXACIN ANHYDROUSACTIVE MOIETYRIX4E89Y14LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]8
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]8
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WELEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]8
TALCINACTIVE INGREDIENT7SEV7J4R1ULEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-451LEVOFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]8Legacy NDC, 1 package rows20151023_bb4b0d6d-efec-4a30-822a-10e7271dd142.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199885levoFLOXacin 500 MG Oral TabletPSNbb4b0d6d-efec-4a30-822a-10e7271dd1428
199885levofloxacin 500 MG Oral TabletSCDbb4b0d6d-efec-4a30-822a-10e7271dd1428

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-451-101054404511010 in 1 BOTTLEHistorical