dorzolamide hydrochloride and timolol maleate preservative free

Generic: dorzolamide hydrochloride and timolol maleate preservative free

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

Drug Facts

Product Profile

Brand Name dorzolamide hydrochloride and timolol maleate preservative free
Generic Name dorzolamide hydrochloride and timolol maleate preservative free
Labeler aurobindo pharma limited
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

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

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-947
Product ID 65862-947_62486059-bf52-4bd3-b902-a1423c9bf649
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207630
Listing Expiration 2026-12-31
Marketing Start 2018-07-24

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 65862947
Hyphenated Format 65862-947

Supplemental Identifiers

RxCUI
1922783
UPC
0365862947154 0365862947185
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 preservative free (source: ndc)
Generic Name dorzolamide hydrochloride and timolol maleate preservative free (source: ndc)
Application Number ANDA207630 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
  • 5 mg/mL
source: ndc
Packaging
  • 12 POUCH in 1 CARTON (65862-947-18) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE
  • 4 POUCH in 1 CARTON (65862-947-60) / 15 VIAL, SINGLE-USE in 1 POUCH (65862-947-15) / .2 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (2)

65862-947-18 12 POUCH in 1 CARTON (65862-947-18) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE 65862-947-60 4 POUCH in 1 CARTON (65862-947-60) / 15 VIAL, SINGLE-USE in 1 POUCH (65862-947-15) / .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 Preservative Free ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "62486059-bf52-4bd3-b902-a1423c9bf649", "openfda": {"upc": ["0365862947154", "0365862947185"], "unii": ["QZO5366EW7", "P8Y54F701R"], "rxcui": ["1922783"], "spl_set_id": ["f41a9cd5-48c8-42eb-bb1b-d0355d981201"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 POUCH in 1 CARTON (65862-947-18)  / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE", "package_ndc": "65862-947-18", "marketing_start_date": "20180724"}, {"sample": false, "description": "4 POUCH in 1 CARTON (65862-947-60)  / 15 VIAL, SINGLE-USE in 1 POUCH (65862-947-15)  / .2 mL in 1 VIAL, SINGLE-USE", "package_ndc": "65862-947-60", "marketing_start_date": "20180724"}], "brand_name": "Dorzolamide Hydrochloride and Timolol Maleate Preservative Free", "product_id": "65862-947_62486059-bf52-4bd3-b902-a1423c9bf649", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "65862-947", "generic_name": "Dorzolamide Hydrochloride and Timolol Maleate Preservative Free", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dorzolamide Hydrochloride and Timolol Maleate Preservative Free", "active_ingredients": [{"name": "DORZOLAMIDE HYDROCHLORIDE", "strength": "20 mg/mL"}, {"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "ANDA207630", "marketing_category": "ANDA", "marketing_start_date": "20180724", "listing_expiration_date": "20261231"}