NDC 17478-514

Dorzolamide HCl and Timolol Maleate

Dorzolamide Hydrochloride And Timolol Maleate

Dorzolamide HCl and Timolol Maleate 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 ID17478-514_023d923a-b1fb-4de0-b69b-08a3131bbfe3
NDC17478-514
Product TypeHuman Prescription Drug
Proprietary NameDorzolamide HCl and Timolol Maleate
Generic NameDorzolamide Hydrochloride And Timolol Maleate
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2014-09-22
Marketing CategoryANDA / ANDA
Application NumberANDA203058
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 Through2022-12-31

Packaging

NDC 17478-514-11

1 BOTTLE, DROPPER in 1 CARTON (17478-514-11) > 10 mL in 1 BOTTLE, DROPPER
Marketing Start Date2014-09-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17478-514-11 [17478051411]

Dorzolamide HCl and Timolol Maleate SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA203058
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-09-22

Drug Details

Active Ingredients

IngredientStrength
DORZOLAMIDE HYDROCHLORIDE20 mg/mL

OpenFDA Data

SPL SET ID:4e7427c3-0195-4212-9839-ab5629906ffc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1923432

    • 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]

    NDC Crossover Matching brand name "Dorzolamide HCl and Timolol Maleate" or generic name "Dorzolamide Hydrochloride And Timolol Maleate"

    NDCBrand NameGeneric Name
    17478-514Dorzolamide HCl and Timolol MaleateDorzolamide Hydrochloride and Timolol Maleate
    50090-2867Dorzolamide HCl and Timolol MaleateDorzolamide Hydrochloride and Timolol Maleate
    17478-605COSOPTDorzolamide Hydrochloride and Timolol Maleate
    17478-604COSOPT PFDorzolamide Hydrochloride and Timolol Maleate
    55545-1007Dorzolamide and TimololDorzolamide 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
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