NDC 43063-638

Levofloxacin

Levofloxacin

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

Product ID43063-638_826aadb5-a444-62b2-e053-2a91aa0a01ed
NDC43063-638
Product TypeHuman Prescription Drug
Proprietary NameLevofloxacin
Generic NameLevofloxacin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-03-22
Marketing CategoryANDA / ANDA
Application NumberANDA200839
Labeler NamePD-Rx Pharmaceuticals, In
Substance NameLEVOFLOXACIN
Active Ingredient Strength500 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43063-638-03

3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-638-03)
Marketing Start Date2016-03-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43063-638-10 [43063063810]

Levofloxacin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200839
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-11-06

NDC 43063-638-03 [43063063803]

Levofloxacin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200839
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-03-18

NDC 43063-638-20 [43063063820]

Levofloxacin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200839
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-09-24

NDC 43063-638-07 [43063063807]

Levofloxacin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200839
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-12-13

NDC 43063-638-14 [43063063814]

Levofloxacin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200839
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-05-17

NDC 43063-638-05 [43063063805]

Levofloxacin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA200839
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-01-12

Drug Details

Active Ingredients

IngredientStrength
LEVOFLOXACIN500 mg/1

OpenFDA Data

SPL SET ID:c2822937-778d-4a2e-8f65-86bc8b92c1f8
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.