Dorzolamide HCl

Product NDC: 50090-2406
Requested package NDC: 50090-2406-0
11-digit product format: 500902406
Labeler code: 50090
Product ID: 50090-2406_40559c5f-6ed7-474b-8f3a-b8616251c685
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dorzolamide HCl
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: A-S Medication Solutions
Application: ANDA090143
Marketing category: ANDA
Marketing start: 2009-06-25
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: 2026-12-31
Current FDA listing: Yes

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-2406	50090-2406-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-2406	50090-2406-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-2406	50090-2406-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A090143-001	DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT		2009-06-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090143-001	AT

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	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090143-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-06-25	`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	A090143-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090143-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090143-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090143-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090143-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090143-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090143-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090143-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090143-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090143-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090143-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090143-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090143-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090143-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090143-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090143-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090143-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090143-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090143-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090143-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090143-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090143-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090143-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090143-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090143-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090143-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090143-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090143-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090143-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090143-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090143-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090143-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090143-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090143-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090143-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090143-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090143-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090143-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090143-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090143-001	AT	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dorzolamide HCl
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DORZOLAMIDE HYDROCHLORIDE	20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
QZO5366EW7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310015	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
91df460c-b896-4600-9d33-e499b49ba1b6	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-2406-0	Dorzolamide HCl	10 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	10		9
50090-2406-0	Dorzolamide HCl	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
50090-2406-0	ML - Milliliter	50090-2406	bc478b74-07b5-409a-9c69-b450182aab9b	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-2406	DORZOLAMIDE HCL SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]	9	Current NDC, Legacy NDC, 2 package rows	20241113_91df460c-b896-4600-9d33-e499b49ba1b6.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 HCl	DORZOLAMIDE HCL	Bausch & Lomb Incorporated	8417d162-65a1-4266-bca7-707af1193bf3	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090143 application number: ANDA090143
Dorzolamide HCl	DORZOLAMIDE HCL	A-S Medication Solutions	91df460c-b896-4600-9d33-e499b49ba1b6	2024-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090143 application number: ANDA090143 ndc (package): 50090-2406-0 ndc (product): 50090-2406 ndc11 (package): 50090240600

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	91df460c-b896-4600-9d33-e499b49ba1b6	9
310015	dorzolamide 20 MG/ML Ophthalmic Solution	SCD	91df460c-b896-4600-9d33-e499b49ba1b6	9
310015	dorzolamide 2 % Ophthalmic Solution	SY	91df460c-b896-4600-9d33-e499b49ba1b6	9
310015	dorzolamide 20 MG/ML (as dorzolamide HCl 22.3 MG/ML) Ophthalmic Solution	SY	91df460c-b896-4600-9d33-e499b49ba1b6	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
50090-2406-0	50090240600	1 BOTTLE, DROPPER in 1 CARTON (50090-2406-0) / 10 mL in 1 BOTTLE, DROPPER	2016-05-18	No	No	Current