NDC 69315-305

Dorzolamide and Timolol

Dorzolamide Hydrochloride And Timolol Maleate Ophthalmic Solution

Dorzolamide and Timolol is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Leading Pharma, Llc. The primary component is Dorzolamide Hydrochloride; Timolol Maleate.

• Product ID: 69315-305_8b5bfd93-6c6b-c8b9-e053-2a95a90a515f
• NDC: 69315-305
• Product Type: Human Prescription Drug
• Proprietary Name: Dorzolamide and Timolol
• Generic Name: Dorzolamide Hydrochloride And Timolol Maleate Ophthalmic Solution
• Dosage Form: Solution
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2017-05-18
• Marketing Category: ANDA / ANDA
• Application Number: ANDA205295
• Labeler Name: Leading Pharma, LLC
• Substance Name: DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
• Active Ingredient Strength: 20 mg/mL; mg/mL
• Pharm Classes: Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69315-305-05

1 BOTTLE, PLASTIC in 1 CARTON (69315-305-05) > 5 mL in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2017-05-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69315-305-05 [69315030505]

Dorzolamide and Timolol SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA205295
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-05-18

NDC 69315-305-10 [69315030510]

Dorzolamide and Timolol SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA205295
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-05-18

Drug Details

Active Ingredients

Ingredient	Strength
DORZOLAMIDE HYDROCHLORIDE	20 mg/mL

OpenFDA Data

• SPL SET ID: c9ae08c5-275d-44b3-9d1e-5d8fedc21b96
• Manufacturer:
  • Leading Pharma, LLC
• UNII:
  • QZO5366EW7
  • P8Y54F701R
• RxNorm Concept Unique ID - RxCUI:
  • 1923432
• UPC Code:
  • 0369315305102
  • 0369315305058

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 and Timolol" or generic name "Dorzolamide Hydrochloride And Timolol Maleate Ophthalmic Solution"

NDC	Brand Name	Generic Name
55545-1007	Dorzolamide and Timolol	Dorzolamide Hydrochloride and Timolol Maleate
69315-305	Dorzolamide and Timolol	Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution
62332-553	Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution	Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution