LEVOFLOXACIN

Product NDC
0409-0528
11-digit product format
004090528
Labeler code
0409
Product ID
0409-0528_5ab673d0-89b8-410e-81ac-d18df31b6819
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOFLOXACIN
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA078579
Marketing category
ANDA
Marketing start
2017-06-12
Marketing end
0000-00-00
Substance
LEVOFLOXACIN
Active strength
5 mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-0528-13ML - Milliliter0409-0528013298df-7b8b-4f7f-b569-f242723b8f9212017-05-03
0409-0528-15ML - Milliliter0409-052897f8a2ab-60be-400d-a5ee-87ec35a1588212017-05-03
0409-0528-23ML - Milliliter0409-052897b3e06a-c996-4acd-9c5d-a65daa28484c12017-05-03
0409-0528-25ML - Milliliter0409-0528d0ae828a-16ed-4696-a35c-efff56be261c12017-05-03
0409-0528-31ML - Milliliter0409-05283a48fd93-1a4e-46a6-b05c-e1aff56a85c112017-05-03
0409-0528-35ML - Milliliter0409-05287b0182fe-f9ed-4be4-84a6-99727eea713e12017-05-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEVOFLOXACINACTIVE INGREDIENT6GNT3Y5LMFLEVOFLOXACIN INJECTION, SOLUTION [HOSPIRA, INC.]1
LEVOFLOXACIN ANHYDROUSACTIVE MOIETYRIX4E89Y14LEVOFLOXACIN INJECTION, SOLUTION [HOSPIRA, INC.]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2LEVOFLOXACIN INJECTION, SOLUTION [HOSPIRA, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLEVOFLOXACIN INJECTION, SOLUTION [HOSPIRA, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILEVOFLOXACIN INJECTION, SOLUTION [HOSPIRA, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-0528-150040905281524 POUCH in 1 CASE (0409-0528-15) > 1 BAG in 1 POUCH > 50 mL in 1 BAG (0409-0528-13) 24 pouch2017-06-120000-00-00NoNoCurrent
0409-0528-250040905282524 POUCH in 1 CASE (0409-0528-25) > 1 BAG in 1 POUCH > 100 mL in 1 BAG (0409-0528-23) 24 pouch2017-06-120000-00-00NoNoCurrent
0409-0528-350040905283524 POUCH in 1 CASE (0409-0528-35) > 1 BAG in 1 POUCH > 150 mL in 1 BAG (0409-0528-31) 24 pouch2017-06-120000-00-00NoNoCurrent