dorzolamide hydrochloride

Generic: dorzolamide hydrochloride

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

Drug Facts

Product Profile

Brand Name dorzolamide hydrochloride
Generic Name dorzolamide hydrochloride
Labeler gland pharma limited
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

dorzolamide hydrochloride 20 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-489
Product ID 68083-489_97a5fb1e-bdb1-43f9-8419-4b12d36d429c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215660
Listing Expiration 2027-12-31
Marketing Start 2022-01-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083489
Hyphenated Format 68083-489

Supplemental Identifiers

RxCUI
310015
UPC
0368083489014
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 hydrochloride (source: ndc)
Application Number ANDA215660 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68083-489-01) / 10 mL in 1 BOTTLE
source: ndc

Packages (1)

68083-489-01 1 BOTTLE in 1 CARTON (68083-489-01) / 10 mL in 1 BOTTLE

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": "97a5fb1e-bdb1-43f9-8419-4b12d36d429c", "openfda": {"upc": ["0368083489014"], "unii": ["QZO5366EW7"], "rxcui": ["310015"], "spl_set_id": ["2023e603-12bb-4502-9f93-0126e0cc24ed"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68083-489-01)  / 10 mL in 1 BOTTLE", "package_ndc": "68083-489-01", "marketing_start_date": "20220127"}], "brand_name": "Dorzolamide Hydrochloride", "product_id": "68083-489_97a5fb1e-bdb1-43f9-8419-4b12d36d429c", "dosage_form": "SOLUTION", "pharm_class": ["Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]"], "product_ndc": "68083-489", "generic_name": "Dorzolamide Hydrochloride", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dorzolamide Hydrochloride", "active_ingredients": [{"name": "DORZOLAMIDE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA215660", "marketing_category": "ANDA", "marketing_start_date": "20220127", "listing_expiration_date": "20271231"}