FDA.reportPublic FDA data

Levofloxacin

Product NDC
71205-002
11-digit product format
712050002
Labeler code
71205
Product ID
71205-002_a630f88d-800c-400f-9da4-1b26c0ee1f85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
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
71205-002-03Levofloxacin03 in 1 BOTTLETABLET, FILM COATED037
71205-002-05Levofloxacin05 in 1 BOTTLETABLET, FILM COATED057
71205-002-07Levofloxacin07 in 1 BOTTLETABLET, FILM COATED077
71205-002-10Levofloxacin10 in 1 BOTTLETABLET, FILM COATED107
71205-002-12Levofloxacin12 in 1 BOTTLETABLET, FILM COATED127
71205-002-14Levofloxacin14 in 1 BOTTLETABLET, FILM COATED147
71205-002-21Levofloxacin21 in 1 BOTTLETABLET, FILM COATED217

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-002LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX LP]6Current NDC, Legacy NDC, 7 package rows20220602_64141d0d-0347-470f-a427-9925a2eb357e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199885levoFLOXacin 500 MG Oral TabletPSN64141d0d-0347-470f-a427-9925a2eb357e7
199885levofloxacin 500 MG Oral TabletSCD64141d0d-0347-470f-a427-9925a2eb357e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-002-03712050002033 TABLET, FILM COATED in 1 BOTTLE (71205-002-03) 2020-10-220000-00-00NoNoCurrent
71205-002-05712050002055 TABLET, FILM COATED in 1 BOTTLE (71205-002-05) 2018-04-020000-00-00NoNoCurrent
71205-002-07712050002077 TABLET, FILM COATED in 1 BOTTLE (71205-002-07) 2018-04-020000-00-00NoNoCurrent
71205-002-107120500021010 TABLET, FILM COATED in 1 BOTTLE (71205-002-10) 2018-04-020000-00-00NoNoCurrent
71205-002-127120500021212 TABLET, FILM COATED in 1 BOTTLE (71205-002-12) 2019-04-010000-00-00NoNoCurrent
71205-002-147120500021414 TABLET, FILM COATED in 1 BOTTLE (71205-002-14) 2018-04-020000-00-00NoNoCurrent
71205-002-217120500022121 TABLET, FILM COATED in 1 BOTTLE (71205-002-21) 2018-04-020000-00-00NoNoCurrent