NDC 53002-1320

Ciprofloxacin

Ciprofloxacin Hydrochloride

Ciprofloxacin is a Topical Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Ciprofloxacin Hydrochloride.

Product ID53002-1320_9476c50d-163c-47d4-85f7-76c782518723
NDC53002-1320
Product TypeHuman Prescription Drug
Proprietary NameCiprofloxacin
Generic NameCiprofloxacin Hydrochloride
Dosage FormSolution/ Drops
Route of AdministrationTOPICAL
Marketing Start Date2008-03-20
Marketing CategoryANDA / ANDA
Application NumberANDA077689
Labeler NameRPK Pharmaceuticals, Inc.
Substance NameCIPROFLOXACIN HYDROCHLORIDE
Active Ingredient Strength4 mg/mL
Pharm ClassesQuinolone Antimicrobial [EPC],Quinolones [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53002-1320-1

2.5 mL in 1 BOTTLE, DROPPER (53002-1320-1)
Marketing Start Date2017-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53002-1320-1 [53002132001]

Ciprofloxacin SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA077689
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-01
Inactivation Date2020-01-31

NDC 53002-1320-2 [53002132002]

Ciprofloxacin SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA077689
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CIPROFLOXACIN HYDROCHLORIDE3.5 mg/mL

OpenFDA Data

SPL SET ID:f55fbaaa-4228-43cf-b452-484e84d204e8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309307
  • Pharmacological Class

    • Quinolone Antimicrobial [EPC]
    • Quinolones [CS]

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

    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
    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
    70518-1278CiprofloxacinCiprofloxacin
    70518-0522CiprofloxacinCiprofloxacin

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.