NDC 0409-0528

LEVOFLOXACIN

Levofloxacin

LEVOFLOXACIN is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Levofloxacin.

Product ID0409-0528_5ab673d0-89b8-410e-81ac-d18df31b6819
NDC0409-0528
Product TypeHuman Prescription Drug
Proprietary NameLEVOFLOXACIN
Generic NameLevofloxacin
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-06-12
Marketing CategoryANDA / ANDA
Application NumberANDA078579
Labeler NameHospira, Inc.
Substance NameLEVOFLOXACIN
Active Ingredient Strength5 mg/mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0409-0528-15

24 POUCH in 1 CASE (0409-0528-15) > 1 BAG in 1 POUCH > 50 mL in 1 BAG (0409-0528-13)
Marketing Start Date2017-06-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-0528-31 [00409052831]

LEVOFLOXACIN INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078579
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-06-12

NDC 0409-0528-13 [00409052813]

LEVOFLOXACIN INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078579
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-06-12

NDC 0409-0528-23 [00409052823]

LEVOFLOXACIN INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078579
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-06-12

NDC 0409-0528-35 [00409052835]

LEVOFLOXACIN INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078579
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-06-12

NDC 0409-0528-15 [00409052815]

LEVOFLOXACIN INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078579
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-06-12

NDC 0409-0528-25 [00409052825]

LEVOFLOXACIN INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078579
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-06-12

Drug Details

Active Ingredients

IngredientStrength
LEVOFLOXACIN5 mg/mL

OpenFDA Data

SPL SET ID:17bcb105-91ff-4240-bba4-29d80001bbe4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1665497
  • 1665515
  • 1665507
  • NDC Crossover Matching brand name "LEVOFLOXACIN" or generic name "Levofloxacin"

    NDCBrand NameGeneric Name
    0121-0872LevofloxacinLevofloxacin
    0143-9315LevofloxacinLevofloxacin
    0143-9316LevofloxacinLevofloxacin
    0143-9317LevofloxacinLevofloxacin
    0143-9720LevofloxacinLevofloxacin
    0143-9721LevofloxacinLevofloxacin
    0143-9722LevofloxacinLevofloxacin
    0143-9775LevofloxacinLevofloxacin
    0143-9776LevofloxacinLevofloxacin
    0143-9777LevofloxacinLevofloxacin
    0409-0528LEVOFLOXACINLEVOFLOXACIN
    0527-1948LevofloxacinLevofloxacin
    0781-5790LevofloxacinLevofloxacin
    0781-5791LevofloxacinLevofloxacin
    0781-5792LevofloxacinLevofloxacin
    0904-6351LevofloxacinLevofloxacin
    0904-6352LevofloxacinLevofloxacin
    0904-6353LevofloxacinLevofloxacin
    10544-143LevofloxacinLevofloxacin
    10544-245LevofloxacinLevofloxacin
    10544-451levofloxacinlevofloxacin
    68071-1860LevofloxacinLevofloxacin
    68071-3089LevofloxacinLevofloxacin
    68071-3051LevofloxacinLevofloxacin
    68071-1932LevofloxacinLevofloxacin
    68071-3091LevofloxacinLevofloxacin
    68071-3093LevofloxacinLevofloxacin
    68071-3166LevofloxacinLevofloxacin
    68071-3218LevofloxacinLevofloxacin
    68071-4101LevofloxacinLevofloxacin
    68071-3271LevofloxacinLevofloxacin
    68071-3236LevofloxacinLevofloxacin
    68071-4422LevofloxacinLevofloxacin
    68071-4340LevofloxacinLevofloxacin
    68071-4547LevofloxacinLevofloxacin
    68071-4623LevofloxacinLevofloxacin
    68071-4726LevofloxacinLevofloxacin
    68071-4512LevofloxacinLevofloxacin
    68071-4738LevofloxacinLevofloxacin
    68084-481LevofloxacinLevofloxacin
    68084-483LevofloxacinLevofloxacin
    68084-482LevofloxacinLevofloxacin
    68180-240LevofloxacinLevofloxacin
    68180-242LevofloxacinLevofloxacin
    68180-241LevofloxacinLevofloxacin
    68382-017levofloxacinlevofloxacin
    68382-015levofloxacinlevofloxacin
    68382-016levofloxacinlevofloxacin
    68382-989levofloxacinlevofloxacin
    68788-6938LevofloxacinLevofloxacin

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.