NDC 50383-261

Dorzolamide Hydrochloride and Timolol Maleate

Dorzolamide Hydrochloride And Timolol Maleate

Dorzolamide Hydrochloride and Timolol Maleate is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Hi-tech Pharmacal Co., Inc.. The primary component is Dorzolamide Hydrochloride; Timolol Maleate.

• Product ID: 50383-261_4e90c721-21e8-46ea-ab49-19f535bf7202
• NDC: 50383-261
• Product Type: Human Prescription Drug
• Proprietary Name: Dorzolamide Hydrochloride and Timolol Maleate
• Generic Name: Dorzolamide Hydrochloride And Timolol Maleate
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2019-02-01
• Marketing Category: NDA / NDA
• Application Number: NDA202667
• Labeler Name: Hi-Tech Pharmacal Co., 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: 2020-12-31

Packaging

NDC 50383-261-61

4 POUCH in 1 CARTON (50383-261-61) > 15 VIAL, SINGLE-USE in 1 POUCH > .2 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2019-02-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50383-261-91 [50383026191]

Dorzolamide Hydrochloride and Timolol Maleate SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA202667
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-02-01

NDC 50383-261-61 [50383026161]

Dorzolamide Hydrochloride and Timolol Maleate SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA202667
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-02-01

Drug Details

Active Ingredients

Ingredient	Strength
DORZOLAMIDE HYDROCHLORIDE	20 mg/mL

OpenFDA Data

• SPL SET ID: 4e90c721-21e8-46ea-ab49-19f535bf7202
• Manufacturer:
  • Hi-Tech Pharmacal Co., Inc.
• UNII:
  • QZO5366EW7
  • P8Y54F701R
• RxNorm Concept Unique ID - RxCUI:
  • 1922783

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

NDC	Brand Name	Generic Name
24208-486	Dorzolamide Hydrochloride and Timolol Maleate	Dorzolamide Hydrochloride and Timolol Maleate
42571-382	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREE
50090-1247	Dorzolamide Hydrochloride and Timolol Maleate	Dorzolamide Hydrochloride and Timolol Maleate
50383-233	Dorzolamide Hydrochloride and Timolol Maleate	Dorzolamide Hydrochloride and Timolol Maleate
50383-261	Dorzolamide Hydrochloride and Timolol Maleate	Dorzolamide Hydrochloride and Timolol Maleate
60429-115	Dorzolamide Hydrochloride and Timolol Maleate	Dorzolamide Hydrochloride and Timolol Maleate
61314-030	Dorzolamide Hydrochloride and Timolol Maleate	Dorzolamide Hydrochloride and Timolol Maleate
70069-051	DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE
17478-605	COSOPT	Dorzolamide Hydrochloride and Timolol Maleate
17478-604	COSOPT PF	Dorzolamide Hydrochloride and Timolol Maleate
55545-1007	Dorzolamide and Timolol	Dorzolamide Hydrochloride and Timolol Maleate
17478-514	Dorzolamide HCl and Timolol Maleate	Dorzolamide Hydrochloride and Timolol Maleate
50090-2867	Dorzolamide HCl and Timolol Maleate	Dorzolamide Hydrochloride and Timolol Maleate
42571-147	Dorzolamide Hydrochloride and Timolol Maleate ophthalmic Solution	Dorzolamide Hydrochloride and Timolol Maleate