dorzolamide hydrochloride and timolol maleate

Generic: dorzolamide hydrochloride and timolol maleate

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dorzolamide hydrochloride and timolol maleate
Generic Name dorzolamide hydrochloride and timolol maleate
Labeler gland pharma limited
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

dorzolamide hydrochloride 20 mg/mL, timolol maleate 5 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-490
Product ID 68083-490_669669a0-0268-4fc0-b73b-7ceeaaea529e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215520
Listing Expiration 2026-12-31
Marketing Start 2022-09-19

Pharmacologic Class

Classes
adrenergic beta-antagonists [moa] carbonic anhydrase inhibitor [epc] carbonic anhydrase inhibitors [moa] beta-adrenergic blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083490
Hyphenated Format 68083-490

Supplemental Identifiers

RxCUI
1923432
UNII
QZO5366EW7 P8Y54F701R

Packaging Origin

Original Packager
true

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 ANDA215520 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68083-490-01) / 10 mL in 1 BOTTLE
source: ndc

Packages (1)

68083-490-01 1 BOTTLE in 1 CARTON (68083-490-01) / 10 mL in 1 BOTTLE

Ingredients (2)

dorzolamide hydrochloride (20 mg/mL) timolol maleate (5 mg/mL)

Linked Drug Pages (1)

Dorzolamide Hydrochloride and Timolol Maleate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "669669a0-0268-4fc0-b73b-7ceeaaea529e", "openfda": {"unii": ["QZO5366EW7", "P8Y54F701R"], "rxcui": ["1923432"], "spl_set_id": ["efab039e-a69d-4306-8305-b1d27781cfe0"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68083-490-01)  / 10 mL in 1 BOTTLE", "package_ndc": "68083-490-01", "marketing_start_date": "20220919"}], "brand_name": "Dorzolamide Hydrochloride and Timolol Maleate", "product_id": "68083-490_669669a0-0268-4fc0-b73b-7ceeaaea529e", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "68083-490", "generic_name": "Dorzolamide Hydrochloride and Timolol Maleate", "labeler_name": "Gland Pharma Limited", "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": "ANDA215520", "marketing_category": "ANDA", "marketing_start_date": "20220919", "listing_expiration_date": "20261231"}