Home NDC 17478-604-30 COSOPT PF
Product NDC 17478-604
Requested package NDC 17478-604-30
11-digit product format 174780604
Labeler code 17478
Product ID 17478-604_9e59a5ca-8bf8-4011-a9aa-2b2d7749cd78
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 2014-05-14
Marketing end 0000-00-00
Substance DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
Active strength 20 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 2023-12-31
Current FDA listing Historical FDA.report record 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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17478-604-00 COSOPT PF 15 in 1 POUCH SOLUTION/ DROPS 15 6 17478-604-00 COSOPT PF 0.2 mL in 1 VIAL, SINGLE-USE SOLUTION/ DROPS 0.2 6 17478-604-01 COSOPT PF 15 in 1 POUCH SOLUTION/ DROPS 15 6 17478-604-01 COSOPT PF 0.2 mL in 1 VIAL, SINGLE-USE SOLUTION/ DROPS 0.2 6 17478-604-15 COSOPT PF 2 in 1 CARTON SOLUTION/ DROPS 2 6 17478-604-30 COSOPT PF 4 in 1 CARTON SOLUTION/ DROPS 4 6 17478-604-90 COSOPT PF 12 in 1 CARTON SOLUTION/ DROPS 12 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Dorzolamide Hydrochloride ACTIVE INGREDIENT QZO5366EW7 COSOPT PF (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN, INC.] 1 Timolol Maleate ACTIVE INGREDIENT P8Y54F701R COSOPT PF (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN, INC.] 1 Dorzolamide ACTIVE MOIETY 9JDX055TW1 COSOPT PF (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN, INC.] 1 Timolol Anhydrous ACTIVE MOIETY 5JKY92S7BR COSOPT PF (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN, INC.] 1 Hydroxyethyl Cellulose (2000 MPA.S AT 1%) INACTIVE INGREDIENT S38J6RZN16 COSOPT PF (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN, INC.] 1 Mannitol INACTIVE INGREDIENT 3OWL53L36A COSOPT PF (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN, INC.] 1 Sodium Citrate INACTIVE INGREDIENT 1Q73Q2JULR COSOPT PF (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN, INC.] 1 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I COSOPT PF (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R COSOPT PF (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17478-604 COSOPT PF (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN] 6 Legacy NDC, 7 package rows 20220503_a8d4e2b5-c7bb-48fc-9314-7095cd77617e.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 17478-604-30 17478060430 4 POUCH in 1 CARTON (17478-604-30) > 15 VIAL, SINGLE-USE in 1 POUCH (17478-604-01) > .2 mL in 1 VIAL, SINGLE-USE 4 pouch 2014-05-14 0000-00-00 No No Current