NDC 68083-395

LEVOFLOXACIN

Levofloxacin

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

Product ID68083-395_d97ee850-7e44-4d56-b45c-b2338cce3b92
NDC68083-395
Product TypeHuman Prescription Drug
Proprietary NameLEVOFLOXACIN
Generic NameLevofloxacin
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-04-22
Marketing CategoryANDA / ANDA
Application NumberANDA205540
Labeler NameGland Pharma Limited
Substance NameLEVOFLOXACIN
Active Ingredient Strength25 mg/mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 68083-395-01

1 VIAL, SINGLE-DOSE in 1 CARTON (68083-395-01) > 30 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2020-04-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68083-395-01 [68083039501]

LEVOFLOXACIN INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA205540
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-22

Drug Details

Active Ingredients

IngredientStrength
LEVOFLOXACIN25 mg/mL

OpenFDA Data

SPL SET ID:ba69722b-d7f2-4519-8a63-9ee91294c499
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1665519
  • 1665517
  • UPC Code
  • 1021123394011
  • 0368083395018
  • 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

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