dorzolamide hydrochloride and timolol maleate (61314-030)

Drug Facts

Product Profile

Brand Name dorzolamide hydrochloride and timolol maleate

Generic Name dorzolamide hydrochloride and timolol maleate

Labeler sandoz inc

Dosage Form SOLUTION

Routes

OPHTHALMIC

Active Ingredients

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

Manufacturer

Sandoz Inc

Identifiers & Regulatory

Product NDC 61314-030

Product ID 61314-030_81902bf8-eb10-4ce2-8d1e-b32ba04adf6a

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA090604

Listing Expiration 2027-12-31

Marketing Start 2010-01-02

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 61314030

Hyphenated Format 61314-030

Supplemental Identifiers

RxCUI

1923432

UPC

0361314030023

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 ANDA090604 (source: ndc)

Routes

OPHTHALMIC

source: ndc

Resolved Composition

Strengths

20 mg/mL
5 mg/mL

source: ndc

Packaging

5 mL in 1 BOTTLE (61314-030-01)
10 mL in 1 BOTTLE (61314-030-02)

source: ndc

Packages (2)

61314-030-01 5 mL in 1 BOTTLE (61314-030-01) 61314-030-02 10 mL in 1 BOTTLE (61314-030-02)

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": "81902bf8-eb10-4ce2-8d1e-b32ba04adf6a", "openfda": {"upc": ["0361314030023"], "unii": ["QZO5366EW7", "P8Y54F701R"], "rxcui": ["1923432"], "spl_set_id": ["78f39126-3e3b-4633-a4e0-c1f09a794eec"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE (61314-030-01)", "package_ndc": "61314-030-01", "marketing_start_date": "20100102"}, {"sample": false, "description": "10 mL in 1 BOTTLE (61314-030-02)", "package_ndc": "61314-030-02", "marketing_start_date": "20100102"}], "brand_name": "Dorzolamide Hydrochloride and Timolol Maleate", "product_id": "61314-030_81902bf8-eb10-4ce2-8d1e-b32ba04adf6a", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "61314-030", "generic_name": "Dorzolamide Hydrochloride and Timolol Maleate", "labeler_name": "Sandoz Inc", "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": "ANDA090604", "marketing_category": "ANDA", "marketing_start_date": "20100102", "listing_expiration_date": "20271231"}