Home NDC 50383-261-61 Dorzolamide Hydrochloride and Timolol Maleate
Product NDC 50383-261
Requested package NDC 50383-261-61
11-digit product format 503830261
Labeler code 50383
Product ID 50383-261_5c6a634a-b5ed-417d-b4b9-bc389538f59d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dorzolamide Hydrochloride and Timolol Maleate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Akorn
Application NDA202667
Marketing category NDA
Marketing start 2019-02-01
Substance DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
Active strength 20; 5 mg/mL; mg/mL
Pharmacologic classes Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50383-261 50383-261-61 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N202667-001 COSOPT PF DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2012-02-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N202667-001 AT2
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2012-02-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2012-02-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2012-02-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2012-02-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2012-02-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2012-02-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2012-02-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2012-02-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2012-02-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2012-02-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2012-02-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2012-02-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2012-02-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2012-02-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2012-02-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2012-02-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2012-02-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2012-02-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2012-02-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2012-02-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT2 RLD, RS 2012-02-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N202667-001 COSOPT PF EQ 2% BASE;EQ 0.5% BASE SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2012-02-01 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Dorzolamide Hydrochloride and Timolol Maleate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DORZOLAMIDE HYDROCHLORIDE 20 mg/mL TIMOLOL MALEATE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination QZO5366EW7 Internal UNII lookup P8Y54F701R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1922783 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50383-261-61 Dorzolamide Hydrochloride and Timolol Maleate 4 in 1 CARTON SOLUTION/ DROPS 4 5 50383-261-61 Dorzolamide Hydrochloride and Timolol Maleate 15 in 1 POUCH SOLUTION/ DROPS 15 5 50383-261-91 Dorzolamide Hydrochloride and Timolol Maleate 15 in 1 POUCH SOLUTION/ DROPS 15 5 50383-261-91 Dorzolamide Hydrochloride and Timolol Maleate 12 in 1 CARTON SOLUTION/ DROPS 12 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50383-261 DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [AKORN] 4 Current NDC, Legacy NDC, 4 package rows 20220528_4e90c721-21e8-46ea-ab49-19f535bf7202.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50383-261-61 50383026161 4 POUCH in 1 CARTON (50383-261-61) > 15 VIAL, SINGLE-USE in 1 POUCH > .2 mL in 1 VIAL, SINGLE-USE 4 pouch 2019-02-01 0000-00-00 No No Current