NDC 0527-1763

Dorzolamide Hydrochloride-Timolol Maleate

Dorzolamide Hydrochloride-timolol Maleate

Dorzolamide Hydrochloride-Timolol Maleate is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Lannett Company, Inc.. The primary component is Dorzolamide Hydrochloride; Timolol Maleate.

• Product ID: 0527-1763_253f7644-0bcd-46ef-b70d-392f733de1cd
• NDC: 0527-1763
• Product Type: Human Prescription Drug
• Proprietary Name: Dorzolamide Hydrochloride-Timolol Maleate
• Generic Name: Dorzolamide Hydrochloride-timolol Maleate
• Dosage Form: Solution
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2014-12-17
• Marketing Category: ANDA / ANDA
• Application Number: ANDA201998
• Labeler Name: Lannett Company, Inc.
• 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: 2021-12-31

Packaging

NDC 0527-1763-73

1 BOTTLE, DROPPER in 1 CARTON (0527-1763-73) > 10 mL in 1 BOTTLE, DROPPER

• Marketing Start Date: 2014-12-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0527-1763-73 [00527176373]

Dorzolamide Hydrochloride-Timolol Maleate SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA201998
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-12-17

Drug Details

Active Ingredients

Ingredient	Strength
DORZOLAMIDE HYDROCHLORIDE	20 mg/mL

OpenFDA Data

• SPL SET ID: 167c5ae9-c354-4658-98ca-8b5b0939c841
• Manufacturer:
  • Lannett Company, Inc.
• UNII:
  • QZO5366EW7
  • P8Y54F701R
• RxNorm Concept Unique ID - RxCUI:
  • 1923432

Pharmacological Class

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