FDA.reportPublic FDA data

Levofloxacin

Product NDC
71335-0434
11-digit product format
713350434
Labeler code
71335
Product ID
71335-0434_fb951968-65db-479b-b313-2ac274ea0df2
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
500 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
LEVOFLOXACIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6GNT3Y5LMF
Rxcui199885

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
71335-0434-0Levofloxacin90 in 1 BOTTLETABLET, FILM COATED90104
71335-0434-1Levofloxacin30 in 1 BOTTLETABLET, FILM COATED30104
71335-0434-2Levofloxacin10 in 1 BOTTLETABLET, FILM COATED10104
71335-0434-3Levofloxacin7 in 1 BOTTLETABLET, FILM COATED7104
71335-0434-4Levofloxacin14 in 1 BOTTLETABLET, FILM COATED14104
71335-0434-5Levofloxacin5 in 1 BOTTLETABLET, FILM COATED5104
71335-0434-6Levofloxacin20 in 1 BOTTLETABLET, FILM COATED20104
71335-0434-7Levofloxacin60 in 1 BOTTLETABLET, FILM COATED60104
71335-0434-8Levofloxacin3 in 1 BOTTLETABLET, FILM COATED3104
71335-0434-9Levofloxacin50 in 1 BOTTLETABLET, FILM COATED50104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0434-2EA - Each71335-043456b487a3-16e5-43be-8d07-087c801e92d812018-05-09
71335-0434-4EA - Each71335-043494d8d05a-75c8-470a-bb81-8497f817a09012018-07-03
71335-0434-5EA - Each71335-04341c492bb5-1a61-4858-a7d4-ec5b9f16de8812018-05-09
71335-0434-6EA - Each71335-0434ff680682-e31b-402a-beca-e71d6ed1ad5612025-01-14
71335-0434-7EA - Each71335-0434ce3d1c28-449b-4298-8012-74c08c0a1b8912018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0434LEVOFLOXACIN (LEVOFLOXACIN) TABLET, FILM COATED [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 10 package rows20240822_804ec547-5b89-4fd0-89b3-7445543e563e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199885levoFLOXacin 500 MG Oral TabletPSN804ec547-5b89-4fd0-89b3-7445543e563e104
199885levofloxacin 500 MG Oral TabletSCD804ec547-5b89-4fd0-89b3-7445543e563e104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0434-07133504340090 TABLET, FILM COATED in 1 BOTTLE (71335-0434-0) 2024-04-030000-00-00NoNoCurrent
71335-0434-17133504340130 TABLET, FILM COATED in 1 BOTTLE (71335-0434-1) 2018-05-070000-00-00NoNoCurrent
71335-0434-27133504340210 TABLET, FILM COATED in 1 BOTTLE (71335-0434-2) 2018-04-190000-00-00NoNoCurrent
71335-0434-3713350434037 TABLET, FILM COATED in 1 BOTTLE (71335-0434-3) 2018-09-050000-00-00NoNoCurrent
71335-0434-47133504340414 TABLET, FILM COATED in 1 BOTTLE (71335-0434-4) 2018-03-050000-00-00NoNoCurrent
71335-0434-5713350434055 TABLET, FILM COATED in 1 BOTTLE (71335-0434-5) 2018-03-300000-00-00NoNoCurrent
71335-0434-67133504340620 TABLET, FILM COATED in 1 BOTTLE (71335-0434-6) 2018-02-130000-00-00NoNoCurrent
71335-0434-77133504340760 TABLET, FILM COATED in 1 BOTTLE (71335-0434-7) 2018-02-140000-00-00NoNoCurrent
71335-0434-8713350434083 TABLET, FILM COATED in 1 BOTTLE (71335-0434-8) 2022-03-100000-00-00NoNoCurrent
71335-0434-97133504340950 TABLET, FILM COATED in 1 BOTTLE (71335-0434-9) 2021-04-210000-00-00NoNoCurrent