FDA.reportPublic FDA data

Levofloxacin

Product NDC
76420-816
11-digit product format
764200816
Labeler code
76420
Product ID
76420-816_184fff28-0fd3-da61-e063-6294a90ac035
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA201043
Marketing category
ANDA
Marketing start
2011-06-20
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
Rxcui199884, 199885, 311296

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
76420-816-00Levofloxacin1000 in 1 BOTTLETABLET, FILM COATED10001
76420-816-05Levofloxacin5 in 1 BOTTLETABLET, FILM COATED51
76420-816-07Levofloxacin7 in 1 BOTTLETABLET, FILM COATED71
76420-816-10Levofloxacin10 in 1 BOTTLETABLET, FILM COATED101
76420-816-14Levofloxacin14 in 1 BOTTLETABLET, FILM COATED141
76420-816-20Levofloxacin20 in 1 BOTTLETABLET, FILM COATED201
76420-816-30Levofloxacin30 in 1 BOTTLETABLET, FILM COATED301
76420-816-50Levofloxacin50 in 1 BOTTLETABLET, FILM COATED501
76420-816-60Levofloxacin60 in 1 BOTTLETABLET, FILM COATED601
76420-816-90Levofloxacin90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-816LEVOFLOXACIN TABLET, FILM COATED [ASCLEMED USA, INC.]1Current NDC, 10 package rows20240514_2e32a8aa-047b-46c6-b67b-d88a9a0a810b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199884levoFLOXacin 250 MG Oral TabletPSN2e32a8aa-047b-46c6-b67b-d88a9a0a810b1
199885levoFLOXacin 500 MG Oral TabletPSN2e32a8aa-047b-46c6-b67b-d88a9a0a810b1
311296levoFLOXacin 750 MG Oral TabletPSN2e32a8aa-047b-46c6-b67b-d88a9a0a810b1
199884levofloxacin 250 MG Oral TabletSCD2e32a8aa-047b-46c6-b67b-d88a9a0a810b1
199885levofloxacin 500 MG Oral TabletSCD2e32a8aa-047b-46c6-b67b-d88a9a0a810b1
311296levofloxacin 750 MG Oral TabletSCD2e32a8aa-047b-46c6-b67b-d88a9a0a810b1
199884levofloxacin (as levofloxacin hemihydrate) 250 MG Oral TabletSY2e32a8aa-047b-46c6-b67b-d88a9a0a810b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76420-816-00764200816001000 TABLET, FILM COATED in 1 BOTTLE (76420-816-00) 2024-05-13NoNoHistorical
76420-816-05764200816055 TABLET, FILM COATED in 1 BOTTLE (76420-816-05) 2024-05-13NoNoHistorical
76420-816-07764200816077 TABLET, FILM COATED in 1 BOTTLE (76420-816-07) 2024-05-13NoNoHistorical
76420-816-107642008161010 TABLET, FILM COATED in 1 BOTTLE (76420-816-10) 2024-05-13NoNoHistorical
76420-816-147642008161414 TABLET, FILM COATED in 1 BOTTLE (76420-816-14) 2024-05-13NoNoHistorical
76420-816-207642008162020 TABLET, FILM COATED in 1 BOTTLE (76420-816-20) 2024-05-13NoNoHistorical
76420-816-307642008163030 TABLET, FILM COATED in 1 BOTTLE (76420-816-30) 2024-05-13NoNoHistorical
76420-816-507642008165050 TABLET, FILM COATED in 1 BOTTLE (76420-816-50) 2024-05-13NoNoHistorical
76420-816-607642008166060 TABLET, FILM COATED in 1 BOTTLE (76420-816-60) 2024-05-13NoNoHistorical
76420-816-907642008169090 TABLET, FILM COATED in 1 BOTTLE (76420-816-90) 2024-05-13NoNoHistorical