FDA.reportPublic FDA data

levofloxacin

Product NDC
68788-8809
11-digit product format
687888809
Labeler code
68788
Product ID
68788-8809_927873c8-8c69-424c-84f4-279ea976ae67
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
2025-01-20
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
68788-8809-1levofloxacin10 in 1 BOTTLETABLET, FILM COATED102
68788-8809-2levofloxacin20 in 1 BOTTLETABLET, FILM COATED202
68788-8809-4levofloxacin14 in 1 BOTTLETABLET, FILM COATED142
68788-8809-7levofloxacin7 in 1 BOTTLETABLET, FILM COATED72

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8809-1EA - Each68788-8809d614e46c-d029-4021-b4f9-e75590a24ac112025-03-04
68788-8809-2EA - Each68788-880961be016a-c2f5-4088-9485-0510434947ed12025-03-04
68788-8809-4EA - Each68788-88098b827d27-a515-4cc2-9186-30e88e9d6c9e12025-03-04
68788-8809-7EA - Each68788-8809060dd37d-272e-4909-aac4-ebc1fc5e167812025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8809LEVOFLOXACIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC]2Current NDC, 4 package rows20250125_067e260c-dc47-4957-a9ff-5a79f17b4ca0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311296levoFLOXacin 750 MG Oral TabletPSN067e260c-dc47-4957-a9ff-5a79f17b4ca02
311296levofloxacin 750 MG Oral TabletSCD067e260c-dc47-4957-a9ff-5a79f17b4ca02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8809-16878888090110 TABLET, FILM COATED in 1 BOTTLE (68788-8809-1) 2025-01-20NoNoHistorical
68788-8809-26878888090220 TABLET, FILM COATED in 1 BOTTLE (68788-8809-2) 2025-01-20NoNoHistorical
68788-8809-46878888090414 TABLET, FILM COATED in 1 BOTTLE (68788-8809-4) 2025-01-20NoNoHistorical
68788-8809-7687888809077 TABLET, FILM COATED in 1 BOTTLE (68788-8809-7) 2025-01-20NoNoHistorical