FDA.reportPublic FDA data

levofloxacin

Product NDC
68788-8772
11-digit product format
687888772
Labeler code
68788
Product ID
68788-8772_6c2423aa-8cfa-481f-97f6-ed4b6f8d0ee6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077652
Marketing category
ANDA
Marketing start
2024-11-20
Substance
LEVOFLOXACIN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
levofloxacin
Listing expiration
2027-12-31

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
68788-8772-1levofloxacin10 in 1 BOTTLETABLET, FILM COATED102
68788-8772-2levofloxacin20 in 1 BOTTLETABLET, FILM COATED202
68788-8772-3levofloxacin30 in 1 BOTTLETABLET, FILM COATED302
68788-8772-4levofloxacin14 in 1 BOTTLETABLET, FILM COATED142
68788-8772-7levofloxacin7 in 1 BOTTLETABLET, FILM COATED72

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8772-1EA - Each68788-8772bc1128ff-1aec-49b7-9882-af10e66aba9512025-01-14
68788-8772-2EA - Each68788-8772ec2fc394-c5f6-4d1a-bf02-77c7c87e92a812025-01-14
68788-8772-3EA - Each68788-87721600db32-2bb1-4cbf-bbde-90e4070eb2cb12025-01-14
68788-8772-4EA - Each68788-877274ce1a9b-ef4c-4a4b-a031-e78a2b66c60712025-01-14
68788-8772-7EA - Each68788-87723ca6c11b-3d23-4094-991a-235edc5f80fd12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8772LEVOFLOXACIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 5 package rows20241122_7a12135e-cbad-4fe1-98f7-53c41d1f2a21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199885levoFLOXacin 500 MG Oral TabletPSN7a12135e-cbad-4fe1-98f7-53c41d1f2a212
199885levofloxacin 500 MG Oral TabletSCD7a12135e-cbad-4fe1-98f7-53c41d1f2a212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8772-16878887720110 TABLET, FILM COATED in 1 BOTTLE (68788-8772-1) 2024-11-20NoNoHistorical
68788-8772-26878887720220 TABLET, FILM COATED in 1 BOTTLE (68788-8772-2) 2024-11-20NoNoHistorical
68788-8772-36878887720330 TABLET, FILM COATED in 1 BOTTLE (68788-8772-3) 2024-11-20NoNoHistorical
68788-8772-46878887720414 TABLET, FILM COATED in 1 BOTTLE (68788-8772-4) 2024-11-20NoNoHistorical
68788-8772-7687888772077 TABLET, FILM COATED in 1 BOTTLE (68788-8772-7) 2024-11-20NoNoHistorical