NDC 65862-947

Dorzolamide Hydrochloride and Timolol Maleate Preservative Free

Dorzolamide Hydrochloride And Timolol Maleate Preservative Free

Dorzolamide Hydrochloride and Timolol Maleate Preservative Free is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Dorzolamide Hydrochloride; Timolol Maleate.

• Product ID: 65862-947_f41a9cd5-48c8-42eb-bb1b-d0355d981201
• NDC: 65862-947
• Product Type: Human Prescription Drug
• Proprietary Name: Dorzolamide Hydrochloride and Timolol Maleate Preservative Free
• Generic Name: Dorzolamide Hydrochloride And Timolol Maleate Preservative Free
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2018-07-24
• Marketing Category: ANDA / ANDA
• Application Number: ANDA207630
• Labeler Name: Aurobindo Pharma Limited
• 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 65862-947-18

12 POUCH in 1 CARTON (65862-947-18) > 15 VIAL, SINGLE-USE in 1 POUCH > .2 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2018-07-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65862-947-15 [65862094715]

Dorzolamide Hydrochloride and Timolol Maleate Preservative Free SOLUTION/ DROPS

• Marketing Category: ANDA
• Application Number: ANDA207630
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-07-24

NDC 65862-947-60 [65862094760]

Dorzolamide Hydrochloride and Timolol Maleate Preservative Free SOLUTION/ DROPS

• Marketing Category: ANDA
• Application Number: ANDA207630
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-07-24

NDC 65862-947-18 [65862094718]

Dorzolamide Hydrochloride and Timolol Maleate Preservative Free SOLUTION/ DROPS

• Marketing Category: ANDA
• Application Number: ANDA207630
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-07-24

Drug Details

Active Ingredients

Ingredient	Strength
DORZOLAMIDE HYDROCHLORIDE	20 mg/mL

OpenFDA Data

• SPL SET ID: f41a9cd5-48c8-42eb-bb1b-d0355d981201
• Manufacturer:
  • Aurobindo Pharma Limited
• UNII:
  • QZO5366EW7
  • P8Y54F701R
• RxNorm Concept Unique ID - RxCUI:
  • 1922783
• UPC Code:
  • 0365862947185

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]

Medicade Reported Pricing

65862094760 DORZOLAMIDE-TIMOLOL 2%-0.5%

Pricing Unit: EA | Drug Type:

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

NDC	Brand Name	Generic Name
65862-947	Dorzolamide Hydrochloride and Timolol Maleate Preservative Free	Dorzolamide Hydrochloride and Timolol Maleate Preservative Free
42571-382	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREE