NDC 53002-1350

Levofloxacin

Levofloxacin

Levofloxacin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Levofloxacin.

Product ID53002-1350_8b41f374-2fe3-455f-bd00-8c648336b7e4
NDC53002-1350
Product TypeHuman Prescription Drug
Proprietary NameLevofloxacin
Generic NameLevofloxacin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-01-09
Marketing CategoryANDA / ANDA
Application NumberANDA202801
Labeler NameRPK Pharmaceuticals, Inc.
Substance NameLEVOFLOXACIN
Active Ingredient Strength500 mg/1
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 53002-1350-1

10 TABLET, FILM COATED in 1 BOTTLE (53002-1350-1)
Marketing Start Date2017-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53002-1350-7 [53002135007]

Levofloxacin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202801
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-01
Inactivation Date2020-01-31

NDC 53002-1350-9 [53002135009]

Levofloxacin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202801
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-01
Inactivation Date2020-01-31

NDC 53002-1350-1 [53002135001]

Levofloxacin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202801
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-01
Inactivation Date2020-01-31

NDC 53002-1350-5 [53002135005]

Levofloxacin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA202801
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
LEVOFLOXACIN500 mg/1

OpenFDA Data

SPL SET ID:daa51cd2-b877-488a-b4a1-3b06487627c6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199885

    • 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.