FDA.reportPublic FDA data

Levofloxacin

Product NDC
68071-4512
11-digit product format
680714512
Labeler code
68071
Product ID
68071-4512_1a907884-caea-cc4d-e063-6394a90acac4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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
68071-4512-1Levofloxacin1 in 1 BOTTLETABLET, FILM COATED17
68071-4512-2Levofloxacin2 in 1 BOTTLETABLET, FILM COATED27
68071-4512-3Levofloxacin3 in 1 BOTTLETABLET, FILM COATED37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4512LEVOFLOXACIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]7Current NDC, Legacy NDC, 3 package rows20240612_72cb9372-e9f8-3ca1-e053-2a91aa0ad820.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199885levoFLOXacin 500 MG Oral TabletPSN72cb9372-e9f8-3ca1-e053-2a91aa0ad8207
199885levofloxacin 500 MG Oral TabletSCD72cb9372-e9f8-3ca1-e053-2a91aa0ad8207

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4512-1680714512011 TABLET, FILM COATED in 1 BOTTLE (68071-4512-1) 2019-12-130000-00-00NoNoCurrent
68071-4512-2680714512022 TABLET, FILM COATED in 1 BOTTLE (68071-4512-2) 2019-12-130000-00-00NoNoCurrent
68071-4512-3680714512033 TABLET, FILM COATED in 1 BOTTLE (68071-4512-3) 2019-12-130000-00-00NoNoCurrent