NDC 53401-301

Ciprofloxacin

Ciprofloxacin

Ciprofloxacin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - New Jersey, Llc. The primary component is Ciprofloxacin Hydrochloride.

Product ID53401-301_9a9adf9b-389b-40f2-980e-38d7c5b15033
NDC53401-301
Product TypeHuman Prescription Drug
Proprietary NameCiprofloxacin
Generic NameCiprofloxacin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2009-08-01
Marketing CategoryANDA / ANDA
Application NumberANDA077859
Labeler NameAphena Pharma Solutions - New Jersey, LLC
Substance NameCIPROFLOXACIN HYDROCHLORIDE
Active Ingredient Strength500 mg/1
Pharm ClassesQuinolone Antimicrobial [EPC],Quinolones [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 53401-301-99

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53401-301-99)
Marketing Start Date2009-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53401-301-99 [53401030199]

Ciprofloxacin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077859
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-08-01
Inactivation Date2019-11-27

NDC 53401-301-20 [53401030120]

Ciprofloxacin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077859
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-08-01
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
CIPROFLOXACIN HYDROCHLORIDE500 mg/1

OpenFDA Data

SPL SET ID:489c5c7d-75e3-4b98-b7d5-3c61e2f98adf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309309

    • Pharmacological Class

    • Quinolone Antimicrobial [EPC]
    • Quinolones [CS]

    NDC Crossover Matching brand name "Ciprofloxacin" or generic name "Ciprofloxacin"

    NDCBrand NameGeneric Name
    0143-2037CiprofloxacinCiprofloxacin
    0143-9927CiprofloxacinCiprofloxacin
    0143-9928CiprofloxacinCiprofloxacin
    0143-9929CiprofloxacinCiprofloxacin
    0172-5312CiprofloxacinCiprofloxacin
    0179-0188CiprofloxacinCiprofloxacin
    0378-1743Ciprofloxacinciprofloxacin
    0378-1745Ciprofloxacinciprofloxacin
    0378-7098Ciprofloxacinciprofloxacin
    0404-7187CiprofloxacinCiprofloxacin Hydrochloride
    0409-4777CIPROFLOXACINCIPROFLOXACIN
    0440-6290CiprofloxacinCiprofloxacin Hydrochloride
    0440-6291CiprofloxacinCiprofloxacin Hydrochloride
    68071-1530CiprofloxacinCiprofloxacin
    68071-1616CiprofloxacinCiprofloxacin
    68071-1893ciprofloxacinciprofloxacin
    68071-3013ciprofloxacinciprofloxacin
    68071-4201ciprofloxacinciprofloxacin
    68071-4122ciprofloxacinciprofloxacin
    68071-4387CiprofloxacinCiprofloxacin
    68071-4492CiprofloxacinCiprofloxacin
    68071-4260ciprofloxacinciprofloxacin
    68071-4403CiprofloxacinCiprofloxacin
    68071-4679ciprofloxacinciprofloxacin
    68071-4576CiprofloxacinCiprofloxacin
    68071-4813CiprofloxacinCiprofloxacin
    68071-4627CiprofloxacinCiprofloxacin
    68084-071CiprofloxacinCiprofloxacin
    68084-070CiprofloxacinCiprofloxacin
    68071-4672ciprofloxacinciprofloxacin
    68084-069CiprofloxacinCiprofloxacin
    68180-392CIPROFLOXACINCIPROFLOXACIN
    68180-393CIPROFLOXACINCIPROFLOXACIN
    68645-060CiprofloxacinCiprofloxacin
    68788-9012ciprofloxacinciprofloxacin
    68788-9330CiprofloxacinCiprofloxacin
    68788-9006CiprofloxacinCiprofloxacin
    68788-9280ciprofloxacinciprofloxacin
    68788-9228CiprofloxacinCiprofloxacin
    68788-9024CiprofloxacinCiprofloxacin
    68788-9944CiprofloxacinCiprofloxacin
    68788-9724CiprofloxacinCiprofloxacin
    68788-9391CiprofloxacinCiprofloxacin
    69117-0008CiprofloxacinCiprofloxacin
    69117-0009CiprofloxacinCiprofloxacin
    69315-308ciprofloxacinciprofloxacin
    70518-0010ciprofloxacinciprofloxacin
    70518-0464ciprofloxacinciprofloxacin
    70518-0340CiprofloxacinCiprofloxacin
    70518-0368ciprofloxacinciprofloxacin
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