FDA.reportPublic FDA data

Levofloxacin

Product NDC
71335-0593
11-digit product format
713350593
Labeler code
71335
Product ID
71335-0593_50fbb1d6-bfc6-4472-b047-fde1564f2530
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202801
Marketing category
ANDA
Marketing start
2015-01-09
Substance
LEVOFLOXACIN
Active strength
750 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Levofloxacin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOFLOXACIN750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6GNT3Y5LMF
Rxcui311296

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0593-1Levofloxacin10 in 1 BOTTLETABLET, FILM COATED10103
71335-0593-2Levofloxacin30 in 1 BOTTLETABLET, FILM COATED30103
71335-0593-3Levofloxacin7 in 1 BOTTLETABLET, FILM COATED7103
71335-0593-4Levofloxacin20 in 1 BOTTLETABLET, FILM COATED20103
71335-0593-5Levofloxacin5 in 1 BOTTLETABLET, FILM COATED5103
71335-0593-6Levofloxacin14 in 1 BOTTLETABLET, FILM COATED14103
71335-0593-7Levofloxacin28 in 1 BOTTLETABLET, FILM COATED28103
71335-0593-8Levofloxacin60 in 1 BOTTLETABLET, FILM COATED60103
71335-0593-9Levofloxacin90 in 1 BOTTLETABLET, FILM COATED90103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0593-1EA - Each71335-0593a38f2dc2-d14c-4373-b79d-d3ffd374b7cd12018-03-08
71335-0593-2EA - Each71335-05936f5db4d4-c5b9-449f-81ee-fd32275321d212018-03-08
71335-0593-3EA - Each71335-05938e657968-a9bc-405b-8e24-2ce3a2c2e6ae12018-03-08
71335-0593-4EA - Each71335-059392866f36-13e8-400e-bbc7-7f57720f99dd12018-03-08
71335-0593-5EA - Each71335-059324003f60-7de6-43f5-ac5f-1fc804b5661512018-03-08
71335-0593-6EA - Each71335-0593b969a21c-476a-44a4-ada8-0aa41d68408912018-03-08
71335-0593-7EA - Each71335-05934e9947f0-ad99-42aa-84a5-a93a4b44b05812018-03-08
71335-0593-8EA - Each71335-05932a9b0007-5ab1-453f-8a2c-36fa7413626512018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0593LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 9 package rows20240828_54a02488-586d-4c4e-8a35-68a067bdd6e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311296levoFLOXacin 750 MG Oral TabletPSN54a02488-586d-4c4e-8a35-68a067bdd6e3103
311296levofloxacin 750 MG Oral TabletSCD54a02488-586d-4c4e-8a35-68a067bdd6e3103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0593-17133505930110 TABLET, FILM COATED in 1 BOTTLE (71335-0593-1) 2018-04-270000-00-00NoNoCurrent
71335-0593-27133505930230 TABLET, FILM COATED in 1 BOTTLE (71335-0593-2) 2018-10-240000-00-00NoNoCurrent
71335-0593-3713350593037 TABLET, FILM COATED in 1 BOTTLE (71335-0593-3) 2018-06-250000-00-00NoNoCurrent
71335-0593-47133505930420 TABLET, FILM COATED in 1 BOTTLE (71335-0593-4) 2018-04-100000-00-00NoNoCurrent
71335-0593-5713350593055 TABLET, FILM COATED in 1 BOTTLE (71335-0593-5) 2018-08-240000-00-00NoNoCurrent
71335-0593-67133505930614 TABLET, FILM COATED in 1 BOTTLE (71335-0593-6) 2018-04-270000-00-00NoNoCurrent
71335-0593-77133505930728 TABLET, FILM COATED in 1 BOTTLE (71335-0593-7) 2019-10-100000-00-00NoNoCurrent
71335-0593-87133505930860 TABLET, FILM COATED in 1 BOTTLE (71335-0593-8) 2018-07-020000-00-00NoNoCurrent
71335-0593-97133505930990 TABLET, FILM COATED in 1 BOTTLE (71335-0593-9) 2023-07-050000-00-00NoNoCurrent