dorzolamide hydrochloride and timolol maleate (42571-382)

Drug Facts

Product Profile

Brand Name dorzolamide hydrochloride and timolol maleate

Generic Name dorzolamide hydrochloride and timolol maleate preservative free

Labeler micro labs limited

Dosage Form SOLUTION/ DROPS

Routes

OPHTHALMIC

Active Ingredients

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

Manufacturer

Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-382

Product ID 42571-382_2882e9af-2d0e-7edb-e063-6394a90afe6c

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA215936

Listing Expiration 2026-12-31

Marketing Start 2022-02-15

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 42571382

Hyphenated Format 42571-382

Supplemental Identifiers

RxCUI

1922783

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 preservative free (source: ndc)

Application Number ANDA215936 (source: ndc)

Routes

OPHTHALMIC

source: ndc

Resolved Composition

Strengths

20 mg/mL
5 mg/mL

source: ndc

Packaging

12 POUCH in 1 CARTON (42571-382-27) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE
4 POUCH in 1 CARTON (42571-382-73) / 15 VIAL, SINGLE-USE in 1 POUCH (42571-382-71) / .2 mL in 1 VIAL, SINGLE-USE

source: ndc

Packages (2)

42571-382-27 12 POUCH in 1 CARTON (42571-382-27) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE 42571-382-73 4 POUCH in 1 CARTON (42571-382-73) / 15 VIAL, SINGLE-USE in 1 POUCH (42571-382-71) / .2 mL in 1 VIAL, SINGLE-USE

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": "2882e9af-2d0e-7edb-e063-6394a90afe6c", "openfda": {"unii": ["QZO5366EW7", "P8Y54F701R"], "rxcui": ["1922783"], "spl_set_id": ["b0a1d984-efee-4751-9797-c09adc2d307d"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 POUCH in 1 CARTON (42571-382-27)  / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE", "package_ndc": "42571-382-27", "marketing_start_date": "20220323"}, {"sample": false, "description": "4 POUCH in 1 CARTON (42571-382-73)  / 15 VIAL, SINGLE-USE in 1 POUCH (42571-382-71)  / .2 mL in 1 VIAL, SINGLE-USE", "package_ndc": "42571-382-73", "marketing_start_date": "20220323"}], "brand_name": "DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE", "product_id": "42571-382_2882e9af-2d0e-7edb-e063-6394a90afe6c", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "42571-382", "generic_name": "DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREE", "labeler_name": "Micro Labs 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": "ANDA215936", "marketing_category": "ANDA", "marketing_start_date": "20220215", "listing_expiration_date": "20261231"}