Levofloxacin

Product NDC
17478-107
11-digit product format
174780107
Labeler code
17478
Product ID
17478-107_1df0a7b7-b4af-4efa-b0b9-74d891c14f4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Akorn
Application
ANDA091644
Marketing category
ANDA
Marketing start
2011-07-01
Marketing end
0000-00-00
Substance
LEVOFLOXACIN
Active strength
25 mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-107-20Levofloxacin20 mL in 1 VIALINJECTION2013
17478-107-20Levofloxacin1 in 1 CARTONINJECTION113
17478-107-30Levofloxacin1 in 1 CARTONINJECTION113
17478-107-30Levofloxacin30 mL in 1 VIALINJECTION3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-107-20ML - Milliliter17478-107ba3d6855-f7d6-4db4-97b1-1e6f4515ff9812012-07-24
17478-107-30ML - Milliliter17478-10753d80233-0ff1-4648-ac4f-ff5091b67f5512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LevofloxacinACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN INJECTION [AKORN, INC.]5
Levofloxacin AnhydrousACTIVE MOIETYRIX4E89Y14LEVOFLOXACIN INJECTION [AKORN, INC.]5
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBLEVOFLOXACIN INJECTION [AKORN, INC.]5
Sodium HydroxideINACTIVE INGREDIENT55X04QC32ILEVOFLOXACIN INJECTION [AKORN, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-107LEVOFLOXACIN INJECTION [AKORN]13Legacy NDC, 4 package rows20220914_4438fed2-7ef5-488f-baa8-39bc65768d1d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665517levoFLOXacin 500 MG in 20 ML InjectionPSN4438fed2-7ef5-488f-baa8-39bc65768d1d13
1665519levoFLOXacin 750 MG in 30 ML InjectionPSN4438fed2-7ef5-488f-baa8-39bc65768d1d13
166551720 ML levofloxacin 25 MG/ML InjectionSCD4438fed2-7ef5-488f-baa8-39bc65768d1d13
166551930 ML levofloxacin 25 MG/ML InjectionSCD4438fed2-7ef5-488f-baa8-39bc65768d1d13
1665517levofloxacin 500 MG per 20 ML InjectionSY4438fed2-7ef5-488f-baa8-39bc65768d1d13
1665519levofloxacin 750 MG per 30 ML InjectionSY4438fed2-7ef5-488f-baa8-39bc65768d1d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17478-107-20174780107201 VIAL in 1 CARTON (17478-107-20) > 20 mL in 1 VIAL1 vial2011-07-010000-00-00NoNoCurrent
17478-107-30174780107301 VIAL in 1 CARTON (17478-107-30) > 30 mL in 1 VIAL1 vial2011-07-010000-00-00NoNoCurrent