dorzolamide hydrochloride and timolol maleate
Generic: dorzolamide hydrochloride and timolol maleate
Labeler: akornDrug Facts
Product Profile
Brand Name
dorzolamide hydrochloride and timolol maleate
Generic Name
dorzolamide hydrochloride and timolol maleate
Labeler
akorn
Dosage Form
SOLUTION/ DROPS
Routes
Active Ingredients
dorzolamide hydrochloride 20 mg/mL, timolol maleate 5 mg/mL
Manufacturer
Identifiers & Regulatory
Product NDC
50383-261
Product ID
50383-261_5c6a634a-b5ed-417d-b4b9-bc389538f59d
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
NDA
Application Number
NDA202667
Listing Expiration
2026-12-31
Marketing Start
2019-02-01
Pharmacologic Class
Classes
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
50383261
Hyphenated Format
50383-261
Supplemental Identifiers
RxCUI
UNII
Packaging Origin
Original Packager
Resolved Product View
Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.
Resolved Identity
Brand Name
dorzolamide hydrochloride and timolol maleate (source: ndc)
Generic Name
dorzolamide hydrochloride and timolol maleate (source: ndc)
Application Number
NDA202667 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 20 mg/mL
- 5 mg/mL
Packaging
- 16 HOW SUPPLIED/STORAGE AND HANDLING Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution 2%/0.5% (Preservative-Free) is supplied in a foil pouch containing 15 low density polyethylene 0.2 mL single-use containers. NDC 50383-261-61, package of 60 single-use vials in 4 pouches. NDC 50383-261-91, package of 180 single-use vials in 12 pouches. Store Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution 2%/0.5% (Preservative-Free) at 20° to 25°C (68° to 77°F). Do not freeze. Store in the original pouch. After the pouch is opened, store the remaining single-use containers in the foil pouch to protect from light. Write down the date you open the foil pouch in the space provided on the pouch. Discard any unused containers 15 days after first opening the pouch.
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 50383-261-61 Dorzalamide HCl/Timolol Maleate Ophthalmic Solution 2%/5% For Topical Application in the Eyes Preservative-Free Sterile Contains: Active Ingredients: Each mL contains 22.3 mg of Dorzolamide Hydrochloride equivalent to 20 mg dorzolamide (2%) and 6.8 mg of Timolol Maleate equivalent to 5 mg timolol (0.5%). Inactive Ingredients: Hydroxyethyl Cellulose, Mannitol, Sodium Citrate, Sodium Hydroxide (to adjust pH) and Water for injection. 60 Single-use Containers: 4 pouches x 15 Single-use Containers (0.2 mL in each single-use container) Rx only Carton Logo
Packages (0)
No package records.
Ingredients (2)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["OPHTHALMIC"], "spl_id": "5c6a634a-b5ed-417d-b4b9-bc389538f59d", "openfda": {"unii": ["QZO5366EW7", "P8Y54F701R"], "rxcui": ["1922783"], "spl_set_id": ["4e90c721-21e8-46ea-ab49-19f535bf7202"], "manufacturer_name": ["Akorn"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Dorzolamide Hydrochloride and Timolol Maleate", "product_id": "50383-261_5c6a634a-b5ed-417d-b4b9-bc389538f59d", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "50383-261", "generic_name": "Dorzolamide Hydrochloride and Timolol Maleate", "labeler_name": "Akorn", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dorzolamide Hydrochloride and Timolol Maleate", "active_ingredients": [{"name": "DORZOLAMIDE HYDROCHLORIDE", "strength": "20 mg/mL"}, {"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "NDA202667", "marketing_category": "NDA", "marketing_start_date": "20190201", "listing_expiration_date": "20261231"}