FDA.reportPublic FDA data

Levofloxacin

Product NDC
43063-459
11-digit product format
430630459
Labeler code
43063
Product ID
43063-459_413846f3-6d6b-3731-e063-6394a90afd7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA201043
Marketing category
ANDA
Marketing start
2011-06-20
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
43063-459-05Levofloxacin5 in 1 BOTTLE, PLASTICTABLET, FILM COATED521
43063-459-07Levofloxacin7 in 1 BOTTLE, PLASTICTABLET, FILM COATED721
43063-459-10Levofloxacin10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1021
43063-459-20Levofloxacin20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-459LEVOFLOXACIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]20Current NDC, Legacy NDC, 4 package rows20240809_814450ae-439e-4a5d-8c60-9b21b6f14be5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311296levoFLOXacin 750 MG Oral TabletPSN814450ae-439e-4a5d-8c60-9b21b6f14be521
311296levofloxacin 750 MG Oral TabletSCD814450ae-439e-4a5d-8c60-9b21b6f14be521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-459-05430630459055 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-459-05) 2012-09-250000-00-00NoNoCurrent
43063-459-07430630459077 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-459-07) 2012-09-250000-00-00NoNoCurrent
43063-459-104306304591010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-459-10) 2012-09-250000-00-00NoNoCurrent
43063-459-204306304592020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-459-20) 2012-09-250000-00-00NoNoCurrent