dorzolamide hydrochloride and timolol maleate

Generic: dorzolamide hydrochloride and timolol maleate

Labeler: aurobindo 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 aurobindo pharma limited
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

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

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-946
Product ID 65862-946_ce99a7ff-3420-478f-90b8-cde6238f158a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207629
Listing Expiration 2026-12-31
Marketing Start 2021-05-14

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 65862946
Hyphenated Format 65862-946

Supplemental Identifiers

RxCUI
1923432
UPC
0365862946010
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 ANDA207629 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (65862-946-01) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

65862-946-01 1 BOTTLE, DROPPER in 1 CARTON (65862-946-01) / 10 mL in 1 BOTTLE, DROPPER

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": "ce99a7ff-3420-478f-90b8-cde6238f158a", "openfda": {"upc": ["0365862946010"], "unii": ["QZO5366EW7", "P8Y54F701R"], "rxcui": ["1923432"], "spl_set_id": ["2d5dcaa5-97ee-40c3-aa29-fcfb91fb78e1"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (65862-946-01)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "65862-946-01", "marketing_start_date": "20210514"}], "brand_name": "Dorzolamide Hydrochloride and Timolol Maleate", "product_id": "65862-946_ce99a7ff-3420-478f-90b8-cde6238f158a", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "65862-946", "generic_name": "Dorzolamide Hydrochloride and Timolol Maleate", "labeler_name": "Aurobindo 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": "ANDA207629", "marketing_category": "ANDA", "marketing_start_date": "20210514", "listing_expiration_date": "20261231"}