NDC 0378-1745

Ciprofloxacin

Ciprofloxacin

Ciprofloxacin is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Ciprofloxacin Hydrochloride; Ciprofloxacin.

Product ID0378-1745_87e1b2c1-be46-408c-855c-ffccc8e03278
NDC0378-1745
Product TypeHuman Prescription Drug
Proprietary NameCiprofloxacin
Generic NameCiprofloxacin
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2007-03-22
Marketing CategoryANDA / ANDA
Application NumberANDA078183
Labeler NameMylan Pharmaceuticals Inc.
Substance NameCIPROFLOXACIN HYDROCHLORIDE; CIPROFLOXACIN
Active Ingredient Strength575 mg/1; mg/1
Pharm ClassesQuinolone Antimicrobial [EPC],Quinolones [CS],Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0378-1745-89

50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1745-89)
Marketing Start Date2007-03-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-1745-01 [00378174501]

Ciprofloxacin TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078183
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-03-22
Marketing End Date2015-05-11

NDC 0378-1745-25 [00378174525]

Ciprofloxacin TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078183
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-03-22
Marketing End Date2015-05-11

NDC 0378-1745-89 [00378174589]

Ciprofloxacin TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078183
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-03-22
Marketing End Date2019-04-30

Drug Details

Active Ingredients

IngredientStrength
CIPROFLOXACIN HYDROCHLORIDE574.9 mg/1

OpenFDA Data

SPL SET ID:b92f9206-325e-4454-9518-4f7464b23f47
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 359383
  • 403921
  • Pharmacological Class

    • Quinolone Antimicrobial [EPC]
    • Quinolones [CS]
    • 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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