COSOPT

Product NDC: 17478-605
11-digit product format: 174780605
Labeler code: 17478
Product ID: 17478-605_f8a5f050-49f1-4d22-b376-1d9f96652366
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dorzolamide Hydrochloride and Timolol Maleate
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Akorn
Application: NDA020869
Marketing category: NDA
Marketing start: 2014-04-30
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	17478-605		I	Inactivated by FDA		2026-08-11
excluded package	package	17478-605	17478-605-10	I	Inactivated by FDA		2026-08-11

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 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17478-605-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17478-605-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17478-605-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17478-605-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17478-605-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17478-605-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17478-605-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17478-605-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17478-605-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17478-605-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17478-605-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17478-605-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17478-605-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17478-605-10	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17478-605-10	`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
N020869-001	COSOPT	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	1998-04-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N020869-001	AT1

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	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	1998-04-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	1998-04-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	1998-04-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	1998-04-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	1998-04-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	1998-04-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	1998-04-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	1998-04-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	1998-04-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	1998-04-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	1998-04-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	1998-04-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	1998-04-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	1998-04-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1998-04-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1998-04-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1998-04-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1998-04-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1998-04-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1998-04-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1998-04-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1998-04-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1998-04-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1998-04-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1998-04-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1998-04-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1998-04-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	1998-04-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	1998-04-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	1998-04-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	1998-04-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	1998-04-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	1998-04-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	RLD, RS	1998-04-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1998-04-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1998-04-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1998-04-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1998-04-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1998-04-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020869-001	COSOPT	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS	1998-04-07	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020869-001	AT1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020869-001	AT1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020869-001	AT1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020869-001	AT1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020869-001	AT1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020869-001	AT1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020869-001	AT1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020869-001	AT1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020869-001	AT1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020869-001	AT1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020869-001	AT1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020869-001	AT1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020869-001	AT1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020869-001	AT1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020869-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020869-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020869-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020869-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020869-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020869-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020869-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020869-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020869-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020869-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020869-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020869-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020869-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020869-001	AT1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020869-001	AT1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020869-001	AT1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020869-001	AT1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020869-001	AT1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020869-001	AT1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020869-001	AT1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020869-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020869-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020869-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020869-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020869-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020869-001	AT	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791	Product name	4	20251208
973dd458-49b1-1bb1-62c6-b37c4b15fe1f	Product name	5	20251121
73103a56-9f57-4f32-a306-a42bfa2fea36	Product name	1	20250505
425025fc-f910-4afe-815b-58d4486ed4f7	Product name	4	20250331
26c5ddae-5c69-622d-e599-5fd583634968	Product name	4	20250313
ee780602-134c-4c60-a2f0-e973ba549cd4	Product name	2	20250304
03f77cb2-b4ad-3c11-8781-787b5ece4291	Product name	3	20240507
273981e4-09e7-45cc-967c-554f628ededf	Product name	3	20230627
97dad5a2-c524-a7b5-dede-82edefe9ce62	Product name	7	20220929
d11e749b-f93e-0ce3-ceda-28fe03d8081d	Product name	2	20190731

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17478-605-10	2024-01-30	C162847	48780-1	c7ccaba7-1905-fd44-e053-dadaa90aa01b	These highlights do not include all the information needed to use COSOPT safely and effectively. See full prescribing information for COSOPT. COSOPT ® (dorzolamide hydrochloride and timolol maleate ophthalmic solution), for topical ophthalmic use Initial U.S. Approval: 1998
17478-605-10	2021-08-10	C162847	48780-1	c7ccaba7-1905-fd44-e053-dadaa90aa01b	These highlights do not include all the information needed to use COSOPT safely and effectively. See full prescribing information for COSOPT. COSOPT ® (dorzolamide hydrochloride and timolol maleate ophthalmic solution), for topical ophthalmic use Initial U.S. Approval: 1998
17478-605-10	2021-07-23	C162847	48780-1	c7ccaba7-1905-fd44-e053-dadaa90aa01b	These highlights do not include all the information needed to use COSOPT safely and effectively. See full prescribing information for COSOPT. COSOPT ® (dorzolamide hydrochloride and timolol maleate ophthalmic solution), for topical ophthalmic use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17478-605-10	COSOPT	10 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	10		9
17478-605-10	COSOPT	1 in 1 CARTON	SOLUTION/ DROPS	1		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-605-10	ML - Milliliter	17478-605	9d99cd33-016f-4d31-a314-666a0c95b37e	1	2014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Dorzolamide Hydrochloride	ACTIVE INGREDIENT	QZO5366EW7	COSOPT (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN]	2
Timolol Maleate	ACTIVE INGREDIENT	P8Y54F701R	COSOPT (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN]	2
Dorzolamide	ACTIVE MOIETY	9JDX055TW1	COSOPT (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN]	2
Timolol Anhydrous	ACTIVE MOIETY	5JKY92S7BR	COSOPT (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN]	2
Benzalkonium Chloride	INACTIVE INGREDIENT	F5UM2KM3W7	COSOPT (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN]	2
Hydroxyethyl Cellulose (2000 MPA.S at 1%)	INACTIVE INGREDIENT	S38J6RZN16	COSOPT (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN]	2
Mannitol	INACTIVE INGREDIENT	3OWL53L36A	COSOPT (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN]	2
Sodium Citrate	INACTIVE INGREDIENT	1Q73Q2JULR	COSOPT (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN]	2
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	COSOPT (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	COSOPT (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-605	COSOPT (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION/ DROPS [AKORN]	9	Legacy NDC, 2 package rows	20221203_b7aa1986-1c24-4733-96b3-e6d8e1d44558.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COSOPT	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	Thea Pharma Inc.	23bdf1c1-3134-4ad1-8e7c-bc655156bdc6	2024-04-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020869 application number: NDA020869

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QZO5366EW7	DORZOLAMIDE HYDROCHLORIDE	130693-82-2	DORZOLAMIDE HYDROCHLORIDE
P8Y54F701R	TIMOLOL MALEATE	26921-17-5	TIMOLOL MALEATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1923433	COSOPT 2 % / 0.5 % Ophthalmic Solution	PSN	b7aa1986-1c24-4733-96b3-e6d8e1d44558	9
1923432	dorzolamide HCl 2 % / timolol maleate 0.5 % Ophthalmic Solution	PSN	b7aa1986-1c24-4733-96b3-e6d8e1d44558	9
1923433	dorzolamide 20 MG/ML / timolol 5 MG/ML Ophthalmic Solution [Cosopt]	SBD	b7aa1986-1c24-4733-96b3-e6d8e1d44558	9
1923432	dorzolamide 20 MG/ML / timolol 5 MG/ML Ophthalmic Solution	SCD	b7aa1986-1c24-4733-96b3-e6d8e1d44558	9
1923433	Cosopt (dorzolamide 20 MG / timolol 5 MG) per ML Ophthalmic Solution	SY	b7aa1986-1c24-4733-96b3-e6d8e1d44558	9
1923433	Cosopt 2 % / 0.5 % Ophthalmic Solution	SY	b7aa1986-1c24-4733-96b3-e6d8e1d44558	9
1923432	dorzolamide 2 % / timolol 0.5 % Ophthalmic Solution	SY	b7aa1986-1c24-4733-96b3-e6d8e1d44558	9
1923432	dorzolamide 20 MG/ML (as dorzolamide HCl 22.26 MG/ML) / timolol 5 MG/ML (as timolol maleate 6.83 MG/ML) Ophthalmic Solution	SY	b7aa1986-1c24-4733-96b3-e6d8e1d44558	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
17478-605-10	17478060510	1 BOTTLE, DROPPER in 1 CARTON (17478-605-10) > 10 mL in 1 BOTTLE, DROPPER	2014-04-30	0000-00-00	No	No	Current