NDC 70069-051

DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE

Dorzolamide Hydrochloride And Timolol Maleate

DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Somerset Therapeutics, Llc. The primary component is Dorzolamide Hydrochloride; Timolol Maleate.

Product ID70069-051_0104402b-97f6-4a13-b66b-031a13ab6720
NDC70069-051
Product TypeHuman Prescription Drug
Proprietary NameDORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE
Generic NameDorzolamide Hydrochloride And Timolol Maleate
Dosage FormSolution
Route of AdministrationOPHTHALMIC
Marketing Start Date2019-06-25
Marketing CategoryANDA / ANDA
Application NumberANDA207523
Labeler NameSomerset Therapeutics, LLC
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 70069-051-12

12 CARTON in 1 BOX (70069-051-12) > 1 BOTTLE in 1 CARTON (70069-051-01) > 10 mL in 1 BOTTLE
Marketing Start Date2019-06-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70069-051-12 [70069005112]

DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE SOLUTION
Marketing CategoryANDA
Application NumberANDA207523
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-25

NDC 70069-051-01 [70069005101]

DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE SOLUTION
Marketing CategoryANDA
Application NumberANDA207523
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-06-25

Drug Details

Active Ingredients

IngredientStrength
DORZOLAMIDE HYDROCHLORIDE20 mg/mL

OpenFDA Data

SPL SET ID:17f04726-725f-4839-911d-47fc5e02baae
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1923432
    • UPC Code
  • 0370069051016

    • Pharmacological Class

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

    NDC Crossover Matching brand name "DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE" or generic name "Dorzolamide Hydrochloride And Timolol Maleate"

    NDCBrand NameGeneric Name
    24208-486Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol Maleate
    42571-382DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEDORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREE
    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
    61314-030Dorzolamide Hydrochloride and Timolol MaleateDorzolamide Hydrochloride and Timolol Maleate
    70069-051DORZOLAMIDE HYDROCHLORIDE 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
    17478-514Dorzolamide HCl and Timolol MaleateDorzolamide Hydrochloride and Timolol Maleate
    50090-2867Dorzolamide HCl and Timolol MaleateDorzolamide Hydrochloride and Timolol Maleate
    42571-147Dorzolamide Hydrochloride and Timolol Maleate ophthalmic SolutionDorzolamide Hydrochloride and Timolol Maleate
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