FDA.reportPublic FDA data

Levofloxacin

Product NDC
71205-058
11-digit product format
712050058
Labeler code
71205
Product ID
71205-058_7dd77e34-db22-4496-9150-19d9c37b45b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA201043
Marketing category
ANDA
Marketing start
2011-06-20
Substance
LEVOFLOXACIN
Active strength
250 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
LEVOFLOXACIN250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6GNT3Y5LMF
Rxcui199884

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
71205-058-21Levofloxacin21 in 1 BOTTLETABLET, FILM COATED213
71205-058-30Levofloxacin30 in 1 BOTTLETABLET, FILM COATED303
71205-058-60Levofloxacin60 in 1 BOTTLETABLET, FILM COATED603
71205-058-90Levofloxacin90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-058LEVOFLOXACIN TABLET, FILM COATED [PROFICIENT RX LP]3Current NDC, Legacy NDC, 4 package rows20191030_30958610-3803-45e6-aa3c-d256decbe6e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199884levoFLOXacin 250 MG Oral TabletPSN30958610-3803-45e6-aa3c-d256decbe6e43
199884levofloxacin 250 MG Oral TabletSCD30958610-3803-45e6-aa3c-d256decbe6e43
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSY30958610-3803-45e6-aa3c-d256decbe6e43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-058-217120500582121 TABLET, FILM COATED in 1 BOTTLE (71205-058-21) 2018-06-010000-00-00NoNoCurrent
71205-058-307120500583030 TABLET, FILM COATED in 1 BOTTLE (71205-058-30) 2018-06-010000-00-00NoNoCurrent
71205-058-607120500586060 TABLET, FILM COATED in 1 BOTTLE (71205-058-60) 2018-06-010000-00-00NoNoCurrent
71205-058-907120500589090 TABLET, FILM COATED in 1 BOTTLE (71205-058-90) 2018-06-010000-00-00NoNoCurrent