Dorzolamide Hydrochloride and Timolol Maleate

Product NDC: 50383-233
11-digit product format: 503830233
Labeler code: 50383
Product ID: 50383-233_d893628a-2d64-464a-b948-2abfafdf83c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dorzolamide Hydrochloride and Timolol Maleate
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Akorn
Application: ANDA077847
Marketing category: ANDA
Marketing start: 2008-10-28
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50383-233		I	Inactivated by FDA	2026-09-09
excluded package	package	50383-233	50383-233-05	D	Discontinued by firm	2026-09-09
excluded package	package	50383-233	50383-233-10	I	Inactivated by FDA	2026-09-09

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	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50383-233-10	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50383-233-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50383-233-10	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50383-233-05	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50383-233-10	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50383-233-05	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50383-233-10	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50383-233-05	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50383-233-10	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50383-233-05	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50383-233-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50383-233-05	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50383-233-10	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50383-233-05	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50383-233-10	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50383-233-05	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50383-233-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50383-233-05	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50383-233-10	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50383-233-05	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50383-233-10	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50383-233-05	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50383-233-10	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50383-233-05	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50383-233-10	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50383-233-10	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50383-233-10	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC			2008-10-28

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 · 42 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
2026-08-18 06:07:40	2026-07	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-10-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-10-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-10-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-10-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-10-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-10-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2008-10-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077847-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077847-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077847-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077847-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077847-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077847-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077847-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077847-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077847-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077847-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077847-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077847-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077847-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077847-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077847-001	AT1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077847-001	AT1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077847-001	AT1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077847-001	AT1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077847-001	AT1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077847-001	AT1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077847-001	AT1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077847-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077847-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077847-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077847-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077847-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077847-001	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
d11e749b-f93e-0ce3-ceda-28fe03d8081d	Product name	2	20190731
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50383-233-05	2024-01-30	C162847	48780-1	1030e365-6253-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution safely and effectively. See full prescribing information for Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution. Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution Initial U.S. Approval: 1998
50383-233-10	2024-01-30	C162847	48780-1	1030e365-6253-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution safely and effectively. See full prescribing information for Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution. Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50383-233-05	Dorzolamide Hydrochloride and Timolol Maleate	1 in 1 BOX	SOLUTION/ DROPS	1	14
50383-233-05	Dorzolamide Hydrochloride and Timolol Maleate	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5	14
50383-233-10	Dorzolamide Hydrochloride and Timolol Maleate	1 in 1 BOX	SOLUTION/ DROPS	1	14
50383-233-10	Dorzolamide Hydrochloride and Timolol Maleate	10 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	10	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50383-233-10	ML - Milliliter	50383-233	2ebbaa0c-5ac2-41a7-bf6a-45a2a8223ed7	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DORZOLAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	QZO5366EW7	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]	6
TIMOLOL MALEATE	ACTIVE INGREDIENT	P8Y54F701R	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]	6
DORZOLAMIDE	ACTIVE MOIETY	9JDX055TW1	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]	6
TIMOLOL ANHYDROUS	ACTIVE MOIETY	5JKY92S7BR	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]	6
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]	6
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]	6
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]	6
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]	6
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.]	6
DORZOLAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	QZO5366EW7	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
TIMOLOL MALEATE	ACTIVE INGREDIENT	P8Y54F701R	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
DORZOLAMIDE	ACTIVE MOIETY	9JDX055TW1	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
TIMOLOL	ACTIVE MOIETY	817W3C6175	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50383-233	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [AKORN]	14	Legacy NDC, 4 package rows	20220602_2a236f05-1ee1-4180-9d80-31518d2204c7.zip

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	2a236f05-1ee1-4180-9d80-31518d2204c7	14
1923432	dorzolamide 20 MG/ML / timolol 5 MG/ML Ophthalmic Solution	SCD	2a236f05-1ee1-4180-9d80-31518d2204c7	14
1923432	dorzolamide 2 % / timolol 0.5 % Ophthalmic Solution	SY	2a236f05-1ee1-4180-9d80-31518d2204c7	14
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	2a236f05-1ee1-4180-9d80-31518d2204c7	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50383-233-05	50383023305	1 BOTTLE, DROPPER in 1 BOX (50383-233-05) > 5 mL in 1 BOTTLE, DROPPER	2009-10-28	0000-00-00	No	No	Current
50383-233-10	50383023310	1 BOTTLE, DROPPER in 1 BOX (50383-233-10) > 10 mL in 1 BOTTLE, DROPPER	2009-10-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dorzolamide Hydrochloride and Timolol Maleate	A-S Medication Solutions	2024-01-08	HUMAN PRESCRIPTION DRUG LABEL	16
Dorzolamide Hydrochloride and Timolol Maleate	Akorn \| Akorn Operating Company LLC \| Akorn AG	2022-06-01	HUMAN PRESCRIPTION DRUG LABEL	14