dorzolamide hydrochloride

Generic: dorzolamide

Labeler: indoco remedies limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dorzolamide hydrochloride
Generic Name dorzolamide
Labeler indoco remedies limited
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

dorzolamide hydrochloride 20 mg/mL

Manufacturer
Indoco Remedies Limited

Identifiers & Regulatory

Product NDC 14445-404
Product ID 14445-404_746e0cc7-7ea7-4090-acb3-69de5fe85be3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202053
Listing Expiration 2026-12-31
Marketing Start 2021-05-14

Pharmacologic Class

Classes
carbonic anhydrase inhibitor [epc] carbonic anhydrase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 14445404
Hyphenated Format 14445-404

Supplemental Identifiers

RxCUI
310015
UPC
0314445404102
UNII
QZO5366EW7

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 (source: ndc)
Generic Name dorzolamide (source: ndc)
Application Number ANDA202053 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DISPENSING in 1 CARTON (14445-404-10) / 10 mL in 1 BOTTLE, DISPENSING
source: ndc

Packages (1)

14445-404-10 1 BOTTLE, DISPENSING in 1 CARTON (14445-404-10) / 10 mL in 1 BOTTLE, DISPENSING

Ingredients (1)

dorzolamide hydrochloride (20 mg/mL)

Linked Drug Pages (1)

Dorzolamide Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "746e0cc7-7ea7-4090-acb3-69de5fe85be3", "openfda": {"upc": ["0314445404102"], "unii": ["QZO5366EW7"], "rxcui": ["310015"], "spl_set_id": ["462a61b2-1ec6-4d18-bc6b-fc03e027caa0"], "manufacturer_name": ["Indoco Remedies Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DISPENSING in 1 CARTON (14445-404-10)  / 10 mL in 1 BOTTLE, DISPENSING", "package_ndc": "14445-404-10", "marketing_start_date": "20210514"}], "brand_name": "Dorzolamide Hydrochloride", "product_id": "14445-404_746e0cc7-7ea7-4090-acb3-69de5fe85be3", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]"], "product_ndc": "14445-404", "generic_name": "Dorzolamide", "labeler_name": "Indoco Remedies Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dorzolamide Hydrochloride", "active_ingredients": [{"name": "DORZOLAMIDE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA202053", "marketing_category": "ANDA", "marketing_start_date": "20210514", "listing_expiration_date": "20261231"}