dorzolamide hydrochloride ophthalmic solution

Generic: dorzolamide hydrochloride

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dorzolamide hydrochloride ophthalmic solution
Generic Name dorzolamide hydrochloride
Labeler micro labs limited
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

dorzolamide hydrochloride 20 mg/mL

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-141
Product ID 42571-141_2b30c4d1-0a5d-3ad8-e063-6394a90a4acb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204778
Listing Expiration 2026-12-31
Marketing Start 2019-11-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42571141
Hyphenated Format 42571-141

Supplemental Identifiers

RxCUI
310015
UPC
0342571141264
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 ophthalmic solution (source: ndc)
Generic Name dorzolamide hydrochloride (source: ndc)
Application Number ANDA204778 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (42571-141-26) / 10 mL in 1 BOTTLE
source: ndc

Packages (1)

42571-141-26 1 BOTTLE in 1 CARTON (42571-141-26) / 10 mL in 1 BOTTLE

Ingredients (1)

dorzolamide hydrochloride (20 mg/mL)

Linked Drug Pages (1)

Dorzolamide Hydrochloride Ophthalmic Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "2b30c4d1-0a5d-3ad8-e063-6394a90a4acb", "openfda": {"upc": ["0342571141264"], "unii": ["QZO5366EW7"], "rxcui": ["310015"], "spl_set_id": ["4698e4e1-c5f6-4db1-9328-74464a85afea"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (42571-141-26)  / 10 mL in 1 BOTTLE", "package_ndc": "42571-141-26", "marketing_start_date": "20191111"}], "brand_name": "Dorzolamide Hydrochloride Ophthalmic Solution", "product_id": "42571-141_2b30c4d1-0a5d-3ad8-e063-6394a90a4acb", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]"], "product_ndc": "42571-141", "generic_name": "Dorzolamide Hydrochloride", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dorzolamide Hydrochloride Ophthalmic Solution", "active_ingredients": [{"name": "DORZOLAMIDE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA204778", "marketing_category": "ANDA", "marketing_start_date": "20191111", "listing_expiration_date": "20261231"}