NDC 17478-604

COSOPT PF

Dorzolamide Hydrochloride And Timolol Maleate

COSOPT PF is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Akorn, Inc.. The primary component is Dorzolamide Hydrochloride; Timolol Maleate.

Product ID17478-604_09191d70-3dcd-4be0-b0f9-d21428d02265
NDC17478-604
Product TypeHuman Prescription Drug
Proprietary NameCOSOPT PF
Generic NameDorzolamide Hydrochloride And Timolol Maleate
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2014-05-14
Marketing CategoryNDA / NDA
Application NumberNDA202667
Labeler NameAkorn, Inc.
Substance NameDORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
Active Ingredient Strength20 mg/mL; mg/mL
Pharm ClassesCarbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 17478-604-15

2 POUCH in 1 CARTON (17478-604-15) > 15 VIAL, SINGLE-USE in 1 POUCH (17478-604-00) > .2 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2014-05-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17478-604-30 [17478060430]

COSOPT PF SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA202667
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-05-14

NDC 17478-604-15 [17478060415]

COSOPT PF SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA202667
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-05-14

NDC 17478-604-00 [17478060400]

COSOPT PF SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA202667
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-05-14

NDC 17478-604-01 [17478060401]

COSOPT PF SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA202667
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-05-14

NDC 17478-604-90 [17478060490]

COSOPT PF SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA202667
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-05-14

Drug Details

Active Ingredients

IngredientStrength
DORZOLAMIDE HYDROCHLORIDE20 mg/mL

OpenFDA Data

SPL SET ID:a8d4e2b5-c7bb-48fc-9314-7095cd77617e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1922783
  • 1922784
  • UPC Code
  • 0317478604013
  • Pharmacological Class

    • Carbonic Anhydrase Inhibitor [EPC]
    • Carbonic Anhydrase Inhibitors [MoA]
    • Adrenergic beta-Antagonists [MoA]
    • beta-Adrenergic Blocker [EPC]
    • Carbonic Anhydrase Inhibitor [EPC]
    • Carbonic Anhydrase Inhibitors [MoA]
    • Adrenergic beta-Antagonists [MoA]
    • beta-Adrenergic Blocker [EPC]

    Medicade Reported Pricing

    17478060430 COSOPT PF EYE DROPS

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "COSOPT PF" or generic name "Dorzolamide Hydrochloride And Timolol Maleate"

    NDCBrand NameGeneric Name
    17478-604COSOPT PFDorzolamide Hydrochloride and Timolol Maleate
    17478-605COSOPTDorzolamide Hydrochloride and Timolol Maleate
    55545-1007Dorzolamide and TimololDorzolamide Hydrochloride and Timolol Maleate
    17478-514Dorzolamide HCl and Timolol MaleateDorzolamide Hydrochloride and Timolol Maleate
    50090-2867Dorzolamide HCl and Timolol MaleateDorzolamide Hydrochloride and Timolol Maleate
    24208-486Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol Maleate
    50090-1247Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol Maleate
    50383-233Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol Maleate
    50383-261Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol Maleate
    60429-115Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol Maleate
    42571-147Dorzolamide Hydrochloride and Timolol Maleate ophthalmic SolutionDorzolamide Hydrochloride and Timolol Maleate

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