Dorzolamide HCl and Timolol Maleate

Product NDC: 50090-2867
11-digit product format: 500902867
Labeler code: 50090
Product ID: 50090-2867_bf1811bf-ad10-450d-9000-d2e13a092f98
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dorzolamide Hydrochloride and Timolol Maleate
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: A-S Medication Solutions
Application: ANDA202054
Marketing category: ANDA
Marketing start: 2015-02-17
Marketing end: 0000-00-00
Substance: DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
Active strength: 20 mg/mL; mg/mL
Pharmacologic classes: Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
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	50090-2867		I	Inactivated by FDA		2026-08-11
excluded package	package	50090-2867	50090-2867-0	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 · 42 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	50090-2867-0	`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	50090-2867-0	`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	50090-2867-0	`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	50090-2867-0	`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	50090-2867-0	`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	50090-2867-0	`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	50090-2867-0	`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	50090-2867-0	`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	50090-2867-0	`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	50090-2867-0	`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	50090-2867-0	`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	50090-2867-0	`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	50090-2867-0	`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	50090-2867-0	`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	50090-2867-0	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50090-2867-0	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50090-2867-0	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50090-2867-0	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	50090-2867-0	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	50090-2867-0	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	50090-2867-0	`9bebd1f3094a…`	`5416666fcb17…`

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
A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1		2014-09-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202054-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2014-09-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2014-09-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2014-09-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2014-09-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2014-09-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2014-09-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2014-09-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2014-09-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2014-09-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202054-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-03	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202054-001	AT1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202054-001	AT1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202054-001	AT1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202054-001	AT1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202054-001	AT1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202054-001	AT1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202054-001	AT1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202054-001	AT1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202054-001	AT1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202054-001	AT1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202054-001	AT1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202054-001	AT1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202054-001	AT1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202054-001	AT1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202054-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202054-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202054-001	AT	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A202054-001	AT	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202054-001	AT1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202054-001	AT1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202054-001	AT1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202054-001	AT1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202054-001	AT1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202054-001	AT1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202054-001	AT1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202054-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202054-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202054-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202054-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202054-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202054-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202054-001	AT1	1	`a50c72e98297…`

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
50090-2867-0	2020-01-31	C162847	48780-1	9d75b9d0-94b7-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use DORZOLAMIDE HYDROCHLORIDE-TIMOLOL MALEATE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for DORZOLAMIDE HYDROCHLORIDE-TIMOLOL MALEATE OPHTHALMIC SOLUTION . DORZOLAMIDE HYDROCHLORIDE-TIMOLOL MALEATE ophthalmic solution, USP Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-2867-0	Dorzolamide HCl and Timolol Maleate	10 mL in 1 BOTTLE, DISPENSING	SOLUTION	10		3
50090-2867-0	Dorzolamide HCl and Timolol Maleate	1 in 1 CARTON	SOLUTION	1		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-2867-0	ML - Milliliter	50090-2867	773ea9d0-e3aa-402e-8676-b94f9aa05a40	1	2019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-2867	DORZOLAMIDE HCL AND TIMOLOL MALEATE (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION [A-S MEDICATION SOLUTIONS]	3	Legacy NDC, 2 package rows	20180215_adf59642-b978-4bce-bdf2-7ee1d12c45a3.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE	Florida Pharmaceutical Products, LLC	02d89d37-cbca-4e06-83ef-2a10f988f1ea	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202054 application number: ANDA202054
DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALETAE	DDORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE	Indoco Remedies Limited	0b75a79a-e048-4bf1-b02b-a72a8b8a0b3b	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202054 application number: ANDA202054

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
1923432	dorzolamide HCl 2 % / timolol maleate 0.5 % Ophthalmic Solution	PSN	adf59642-b978-4bce-bdf2-7ee1d12c45a3	3
1923432	dorzolamide 20 MG/ML / timolol 5 MG/ML Ophthalmic Solution	SCD	adf59642-b978-4bce-bdf2-7ee1d12c45a3	3
1923432	dorzolamide 2 % / timolol 0.5 % Ophthalmic Solution	SY	adf59642-b978-4bce-bdf2-7ee1d12c45a3	3
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	adf59642-b978-4bce-bdf2-7ee1d12c45a3	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
50090-2867-0	50090286700	10 mL in 1 BOTTLE, DISPENSING	10 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dorzolamide HCl and Timolol Maleate	A-S Medication Solutions	2018-02-13	HUMAN PRESCRIPTION DRUG LABEL	3