FDA.reportPublic FDA data

Levofloxacin

Product NDC
70954-852
11-digit product format
709540852
Labeler code
70954
Product ID
70954-852_b548d9b8-70c9-41d4-8103-41568d50f561
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
SOLUTION
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA091678
Marketing category
ANDA
Marketing start
2024-03-26
Substance
LEVOFLOXACIN
Active strength
25 mg/mL
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
LEVOFLOXACIN25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6GNT3Y5LMF
Rxcui477391

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70954-852-10Levofloxacin100 mL in 1 BOTTLESOLUTION1002
70954-852-20Levofloxacin200 mL in 1 BOTTLESOLUTION2002
70954-852-30Levofloxacin480 mL in 1 BOTTLESOLUTION4802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-852-10ML - Milliliter70954-8521754ff7b-431b-4598-8130-ae6876185a9c12024-04-05
70954-852-20ML - Milliliter70954-852353b2c46-1224-4c79-8059-cb4baced592e12024-04-05
70954-852-30ML - Milliliter70954-852d197fb3a-dfe6-4457-979a-0a155f14b2fc12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-852LEVOFLOXACIN SOLUTION [ANI PHARMACEUTICALS, INC.]2Current NDC, 3 package rows20240625_a894e40b-77e4-439b-b0f8-9a5cc7a1dd90.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477391levoFLOXacin 25 MG in 1 mL Oral SolutionPSNa894e40b-77e4-439b-b0f8-9a5cc7a1dd902
477391levofloxacin 25 MG/ML Oral SolutionSCDa894e40b-77e4-439b-b0f8-9a5cc7a1dd902
477391levofloxacin 25 MG per 1 ML Oral SolutionSYa894e40b-77e4-439b-b0f8-9a5cc7a1dd902
477391levofloxacin 250 MG per 10 ML Oral SolutionSYa894e40b-77e4-439b-b0f8-9a5cc7a1dd902
477391levofloxacin 500 MG per 20 ML Oral SolutionSYa894e40b-77e4-439b-b0f8-9a5cc7a1dd902

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70954-852-1070954085210100 mL in 1 BOTTLE (70954-852-10) 100 ml2024-03-26NoNoCurrent
70954-852-2070954085220200 mL in 1 BOTTLE (70954-852-20) 200 ml2024-03-26NoNoCurrent
70954-852-3070954085230480 mL in 1 BOTTLE (70954-852-30) 480 ml2024-03-26NoNoCurrent