NDC 21695-041

Levofloxacin

Levofloxacin

Levofloxacin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Levofloxacin.

Product ID21695-041_f82ee9e3-5119-4be0-883c-5831386baef6
NDC21695-041
Product TypeHuman Prescription Drug
Proprietary NameLevofloxacin
Generic NameLevofloxacin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2011-06-20
Marketing CategoryANDA / ANDA
Application NumberANDA076361
Labeler NameRebel Distributors Corp
Substance NameLEVOFLOXACIN
Active Ingredient Strength750 mg/1
Pharm ClassesQuinolone Antimicrobial [EPC],Quinolones [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-041-05

5 TABLET, FILM COATED in 1 BOTTLE (21695-041-05)
Marketing Start Date2011-06-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-041-05 [21695004105]

Levofloxacin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076361
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-06-20
Inactivation Date2019-09-24

NDC 21695-041-10 [21695004110]

Levofloxacin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA076361
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-06-20
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
LEVOFLOXACIN750 mg/1

OpenFDA Data

SPL SET ID:312e65cb-897f-4c24-b17b-be7e8ce469bb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311296
  • 199885
  • 199884

    • Pharmacological Class

    • Quinolone Antimicrobial [EPC]
    • Quinolones [CS]

    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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.