Levofloxacin

Product NDC
53217-318
11-digit product format
532170318
Labeler code
53217
Product ID
53217-318_fc36fb09-9f95-41c6-9b16-a1ed5094464e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA076890
Marketing category
ANDA
Marketing start
2012-03-30
Marketing end
0000-00-00
Substance
LEVOFLOXACIN
Active strength
750 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-318-07Levofloxacin100 in 1 BOTTLETABLET1001
53217-318-81Levofloxacin20 in 1 BOTTLETABLET201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-318-07EA - Each53217-318a6e7db26-b464-4779-b069-ccccb7d15db812017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-318LEVOFLOXACIN TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20170606_4a4ea793-821f-4727-95d8-5986ede9a4f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311296levoFLOXacin 750 MG Oral TabletPSN4a4ea793-821f-4727-95d8-5986ede9a4f41
311296levofloxacin 750 MG Oral TabletSCD4a4ea793-821f-4727-95d8-5986ede9a4f41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-318-0753217031807100 in 1 BOTTLEHistorical
53217-318-815321703188120 in 1 BOTTLEHistorical