FDA.reportPublic FDA data

Levofloxacin

Product NDC
0409-3330
11-digit product format
004093330
Labeler code
0409
Product ID
0409-3330_3c0a7c98-14cf-4b2e-a4f8-0e6b7b17cd2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levofloxacin
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc
Application
ANDA090343
Marketing category
ANDA
Marketing start
2024-05-20
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
0409-3330-01Levofloxacin100 mL in 1 BAGINJECTION, SOLUTION1002
0409-3330-01Levofloxacin1 in 1 POUCHINJECTION, SOLUTION12
0409-3330-24Levofloxacin24 in 1 CARTONINJECTION, SOLUTION242

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-3330-01ML - Milliliter0409-3330c9783ebb-a246-42ab-a375-e34bbce14fe512024-07-12
0409-3330-24ML - Milliliter0409-333022048d6e-ee4e-4225-a2f1-1050a8c3f31a12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-3330LEVOFLOXACIN INJECTION, SOLUTION [HOSPIRA, INC]1Current NDC, 3 package rows20240520_5a1534af-aa1c-4f1d-ba9f-9415b14e1af2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665497levoFLOXacin 250 MG in 50 ML InjectionPSN5a1534af-aa1c-4f1d-ba9f-9415b14e1af22
1665507levoFLOXacin 500 MG in 100 ML InjectionPSN5a1534af-aa1c-4f1d-ba9f-9415b14e1af22
1665515levoFLOXacin 750 MG in 150 ML InjectionPSN5a1534af-aa1c-4f1d-ba9f-9415b14e1af22
1665507100 ML levofloxacin 5 MG/ML InjectionSCD5a1534af-aa1c-4f1d-ba9f-9415b14e1af22
1665515150 ML levofloxacin 5 MG/ML InjectionSCD5a1534af-aa1c-4f1d-ba9f-9415b14e1af22
166549750 ML levofloxacin 5 MG/ML InjectionSCD5a1534af-aa1c-4f1d-ba9f-9415b14e1af22
1665497levofloxacin 250 MG per 50 ML InjectionSY5a1534af-aa1c-4f1d-ba9f-9415b14e1af22
1665507levofloxacin 500 MG per 100 ML InjectionSY5a1534af-aa1c-4f1d-ba9f-9415b14e1af22
1665515levofloxacin 750 MG per 150 ML InjectionSY5a1534af-aa1c-4f1d-ba9f-9415b14e1af22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0409-3330-0100409333001100 mL in 1 BAG100 mlHistorical
0409-3330-240040933302424 POUCH in 1 CARTON (0409-3330-24) / 1 BAG in 1 POUCH (0409-3330-01) / 100 mL in 1 BAG24 pouch2024-05-20NoNoCurrent