Levofloxacin

Product NDC
55150-244
11-digit product format
551500244
Labeler code
55150
Product ID
55150-244_8cb7f273-fc11-48e7-b2ef-a5290ab7ac4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin in 5% Dextrose
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA206919
Marketing category
ANDA
Marketing start
2016-02-10
Substance
LEVOFLOXACIN
Active strength
500 mg/100mL
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/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6GNT3Y5LMF
Rxcui1665497, 1665507, 1665515

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
addb5519-f7ae-4d4e-b9ca-f782a1597fd3Product name220210610
fb758c6a-fdee-40a8-99c2-46f79c3ff90cProduct name420200807
1a81e9a9-11c3-4fcf-b5dd-f6798fef8e6dProduct name120190618
aea4a616-4dfe-45f6-94bb-8b9063056cebProduct name620190611
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
2246ce8e-a477-4dc3-b6d6-fe9973c18ed1Product name120180821
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
5a6c788d-375b-4565-a8ae-67c179a30c93Product name120180212
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-244-47Levofloxacin24 in 1 CARTONINJECTION, SOLUTION249
55150-244-47Levofloxacin1 in 1 POUCHINJECTION, SOLUTION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-244-47ML - Milliliter55150-244947e1984-92fa-43fc-8f34-e5e941d2dc5f12016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-244LEVOFLOXACIN (LEVOFLOXACIN IN 5% DEXTROSE) INJECTION, SOLUTION [EUGIA US LLC]9Current NDC, Legacy NDC, 2 package rows20240627_7d3f83bf-2db7-4657-9538-406adf321ad5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665497levoFLOXacin 250 MG in 50 ML InjectionPSN7d3f83bf-2db7-4657-9538-406adf321ad59
1665507levoFLOXacin 500 MG in 100 ML InjectionPSN7d3f83bf-2db7-4657-9538-406adf321ad59
1665515levoFLOXacin 750 MG in 150 ML InjectionPSN7d3f83bf-2db7-4657-9538-406adf321ad59
1665507100 ML levofloxacin 5 MG/ML InjectionSCD7d3f83bf-2db7-4657-9538-406adf321ad59
1665515150 ML levofloxacin 5 MG/ML InjectionSCD7d3f83bf-2db7-4657-9538-406adf321ad59
166549750 ML levofloxacin 5 MG/ML InjectionSCD7d3f83bf-2db7-4657-9538-406adf321ad59
1665497levofloxacin 250 MG per 50 ML InjectionSY7d3f83bf-2db7-4657-9538-406adf321ad59
1665507levofloxacin 500 MG per 100 ML InjectionSY7d3f83bf-2db7-4657-9538-406adf321ad59
1665515levofloxacin 750 MG per 150 ML InjectionSY7d3f83bf-2db7-4657-9538-406adf321ad59

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55150-244-475515002444724 POUCH in 1 CARTON (55150-244-47) / 1 BAG in 1 POUCH / 100 mL in 1 BAG24 pouch2016-02-100000-00-00NoNoCurrent