Dorzolamide Hydrochloride

Product NDC: 50090-1246
11-digit product format: 500901246
Labeler code: 50090
Product ID: 50090-1246_d60eb0bc-9eba-428e-a96d-e59cc69eca57
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dorzolamide Hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: A-S Medication Solutions
Application: ANDA077846
Marketing category: ANDA
Marketing start: 2008-10-28
Marketing end: 0000-00-00
Substance: DORZOLAMIDE HYDROCHLORIDE
Active strength: 20 mg/mL
Pharmacologic classes: Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	50090-1246		I	Inactivated by FDA		2026-08-17
excluded package	package	50090-1246	50090-1246-0	I	Inactivated by FDA		2026-08-17

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	50090-1246-0	`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	50090-1246-0	`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	50090-1246-0	`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	50090-1246-0	`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	50090-1246-0	`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	50090-1246-0	`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	50090-1246-0	`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	50090-1246-0	`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	50090-1246-0	`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	50090-1246-0	`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	50090-1246-0	`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	50090-1246-0	`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	50090-1246-0	`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	50090-1246-0	`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	50090-1246-0	`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
A077846-001	DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	EQ 2% 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	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		2008-10-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2008-10-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077846-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% 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	A077846-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077846-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077846-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077846-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077846-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077846-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077846-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077846-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077846-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077846-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077846-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077846-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077846-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077846-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077846-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077846-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077846-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077846-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077846-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077846-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077846-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077846-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077846-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077846-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077846-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077846-001	AT	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
973dd458-49b1-1bb1-62c6-b37c4b15fe1f	Product name	5	20251121
03f77cb2-b4ad-3c11-8781-787b5ece4291	Product name	3	20240507
97dad5a2-c524-a7b5-dede-82edefe9ce62	Product name	7	20220929

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-1246-0	2023-01-30	C162847	48780-1	f386c649-cc43-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use Dorzolamide Hydrochloride Ophthalmic Solution safely and effectively. See full prescribing information for Dorzolamide Hydrochloride Ophthalmic Solution. Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-1246-0	Dorzolamide Hydrochloride	10 mL in 1 BOTTLE	SOLUTION/ DROPS	10		15
50090-1246-0	Dorzolamide Hydrochloride	1 in 1 CARTON	SOLUTION/ DROPS	1		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-1246-0	ML - Milliliter	50090-1246	56562e0e-b867-4324-be4c-4d44494a00c2	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-1246	DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]	15	Legacy NDC, 2 package rows	20210416_657c5121-32e2-440a-ae04-0b43e87f9f77.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QZO5366EW7	DORZOLAMIDE HYDROCHLORIDE	130693-82-2	DORZOLAMIDE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310015	dorzolamide HCl 2 % Ophthalmic Solution	PSN	657c5121-32e2-440a-ae04-0b43e87f9f77	15
310015	dorzolamide 20 MG/ML Ophthalmic Solution	SCD	657c5121-32e2-440a-ae04-0b43e87f9f77	15
310015	dorzolamide 2 % Ophthalmic Solution	SY	657c5121-32e2-440a-ae04-0b43e87f9f77	15
310015	dorzolamide 20 MG/ML (as dorzolamide HCl 22.3 MG/ML) Ophthalmic Solution	SY	657c5121-32e2-440a-ae04-0b43e87f9f77	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-1246-0	50090124600	1 BOTTLE in 1 CARTON (50090-1246-0) > 10 mL in 1 BOTTLE	1 bottle	2014-11-28	0000-00-00	No	No	Current