FDA.reportPublic FDA data

Levofloxacin

Product NDC
80425-0007
11-digit product format
804250007
Labeler code
80425
Product ID
80425-0007_2a980dca-ab6c-6ad6-e063-6294a90aaca8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ADVANCED RX PHARMACY OF TENNESSEE, LLC
Application
ANDA202801
Marketing category
ANDA
Marketing start
2015-01-19
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
80425-0007-1Levofloxacin14 in 1 BOTTLETABLET, FILM COATED149
80425-0007-2Levofloxacin30 in 1 BOTTLETABLET, FILM COATED309
80425-0007-3Levofloxacin20 in 1 BOTTLETABLET, FILM COATED209
80425-0007-4Levofloxacin10 in 1 BOTTLETABLET, FILM COATED109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0007-1EA - Each80425-00075fd0d6e7-bd24-4795-b920-75653a2855b012023-06-06
80425-0007-2EA - Each80425-00072ad5205e-8170-4cae-a8ce-3707a984aad212023-06-06
80425-0007-3EA - Each80425-00073cceb5da-8e80-4123-9818-e935e0e59a3412023-06-06
80425-0007-4EA - Each80425-000793011904-4c08-413a-bad1-a9699d4f38de12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0007LEVOFLOXACIN TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]9Current NDC, Legacy NDC, 4 package rows20250101_af4b7333-4f77-4ec9-e053-2a95a90a16d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199885levoFLOXacin 500 MG Oral TabletPSNaf4b7333-4f77-4ec9-e053-2a95a90a16d29
199885levofloxacin 500 MG Oral TabletSCDaf4b7333-4f77-4ec9-e053-2a95a90a16d29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80425-0007-18042500070114 TABLET, FILM COATED in 1 BOTTLE (80425-0007-1) 2015-01-190000-00-00NoNoCurrent
80425-0007-28042500070230 TABLET, FILM COATED in 1 BOTTLE (80425-0007-2) 2015-01-190000-00-00NoNoCurrent
80425-0007-38042500070320 TABLET, FILM COATED in 1 BOTTLE (80425-0007-3) 2015-01-190000-00-00NoNoCurrent
80425-0007-48042500070410 TABLET, FILM COATED in 1 BOTTLE (80425-0007-4) 2023-03-30NoNoCurrent