Dorzolamide Hydrochloride

Product NDC: 68083-489
11-digit product format: 680830489
Labeler code: 68083
Product ID: 68083-489_97a5fb1e-bdb1-43f9-8419-4b12d36d429c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dorzolamide Hydrochloride
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Gland Pharma Limited
Application: ANDA215660
Marketing category: ANDA
Marketing start: 2022-01-27
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: 2027-12-31
Current FDA listing: Yes

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
A215660-001	DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT		2022-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215660-001	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.

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	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215660-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-01-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A215660-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215660-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215660-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215660-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215660-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215660-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215660-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215660-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215660-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215660-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215660-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215660-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215660-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215660-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215660-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215660-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215660-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215660-001	AT	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215660-001	AT	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215660-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215660-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215660-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215660-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215660-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215660-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215660-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215660-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215660-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215660-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215660-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215660-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215660-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215660-001	AT	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dorzolamide Hydrochloride
Listing expiration: 2027-12-31

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
2023e603-12bb-4502-9f93-0126e0cc24ed	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68083-489-01	Dorzolamide Hydrochloride	1 in 1 CARTON	SOLUTION	1		8
68083-489-01	Dorzolamide Hydrochloride	10 mL in 1 BOTTLE	SOLUTION	10		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-489	DORZOLAMIDE HYDROCHLORIDE SOLUTION [GLAND PHARMA LIMITED]	7	Current NDC, Legacy NDC, 2 package rows	20240430_2023e603-12bb-4502-9f93-0126e0cc24ed.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dorzolamide Hydrochloride	DORZOLAMIDE HYDROCHLORIDE	Sagent Pharmaceuticals	0246463c-6c24-4611-8e22-2d5254ace66a	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215660 application number: ANDA215660
Dorzolamide Hydrochloride	DORZOLAMIDE HYDROCHLORIDE	FOSUN PHARMA USA INC	ef173b63-499f-301b-e053-2995a90a4771	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215660 application number: ANDA215660
Dorzolamide Hydrochloride	DORZOLAMIDE HYDROCHLORIDE	Gland Pharma Limited	2023e603-12bb-4502-9f93-0126e0cc24ed	2025-05-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215660 application number: ANDA215660 ndc (product): 68083-489

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	2023e603-12bb-4502-9f93-0126e0cc24ed	8
310015	dorzolamide 20 MG/ML Ophthalmic Solution	SCD	2023e603-12bb-4502-9f93-0126e0cc24ed	8
310015	dorzolamide 2 % Ophthalmic Solution	SY	2023e603-12bb-4502-9f93-0126e0cc24ed	8
310015	dorzolamide 20 MG/ML (as dorzolamide HCl 22.3 MG/ML) Ophthalmic Solution	SY	2023e603-12bb-4502-9f93-0126e0cc24ed	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68083-489-01	68083048901	1 BOTTLE in 1 CARTON (68083-489-01) / 10 mL in 1 BOTTLE	1 bottle	2022-01-27	0000-00-00	No	No	Current