Dorzolamide Hydrochloride and Timolol Maleate

Product NDC: 68083-490
11-digit product format: 680830490
Labeler code: 68083
Product ID: 68083-490_669669a0-0268-4fc0-b73b-7ceeaaea529e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dorzolamide Hydrochloride and Timolol Maleate
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Gland Pharma Limited
Application: ANDA215520
Marketing category: ANDA
Marketing start: 2022-09-19
Substance: DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
Active strength: 20; 5 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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1		2022-09-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215520-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2022-09-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2022-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2022-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2022-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2022-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2022-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2022-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2022-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2022-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2022-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2022-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2022-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2022-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2022-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2022-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2022-09-19	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2022-09-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2022-09-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2022-09-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2022-09-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2022-09-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2022-09-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2022-09-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-09-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-09-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-09-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2022-09-19	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215520-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2022-09-19	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A215520-001	AT1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215520-001	AT1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215520-001	AT1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215520-001	AT1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215520-001	AT1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215520-001	AT1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215520-001	AT1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215520-001	AT1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215520-001	AT1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215520-001	AT1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215520-001	AT1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215520-001	AT1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215520-001	AT1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215520-001	AT1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215520-001	AT1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215520-001	AT1	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215520-001	AT1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215520-001	AT1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215520-001	AT1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215520-001	AT1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215520-001	AT1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215520-001	AT1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215520-001	AT1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215520-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215520-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215520-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215520-001	AT	1	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215520-001	AT1	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Dorzolamide Hydrochloride and Timolol Maleate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DORZOLAMIDE HYDROCHLORIDE	20 mg/mL
TIMOLOL MALEATE	5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
QZO5366EW7	Internal UNII lookup
P8Y54F701R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1923432	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
efab039e-a69d-4306-8305-b1d27781cfe0	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68083-490-01	Dorzolamide Hydrochloride and Timolol Maleate	10 mL in 1 BOTTLE	SOLUTION/ DROPS	10		6
68083-490-01	Dorzolamide Hydrochloride and Timolol Maleate	1 in 1 CARTON	SOLUTION/ DROPS	1		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-490	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [GLAND PHARMA LIMITED]	6	Current NDC, Legacy NDC, 2 package rows	20240517_efab039e-a69d-4306-8305-b1d27781cfe0.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dorzolamide Hydrochloride and Timolol Maleate	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	Gland Pharma Limited	efab039e-a69d-4306-8305-b1d27781cfe0	2024-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215520 application number: ANDA215520 ndc (product): 68083-490

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	efab039e-a69d-4306-8305-b1d27781cfe0	6
1923432	dorzolamide 20 MG/ML / timolol 5 MG/ML Ophthalmic Solution	SCD	efab039e-a69d-4306-8305-b1d27781cfe0	6
1923432	dorzolamide 2 % / timolol 0.5 % Ophthalmic Solution	SY	efab039e-a69d-4306-8305-b1d27781cfe0	6
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	efab039e-a69d-4306-8305-b1d27781cfe0	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68083-490-01	68083049001	1 BOTTLE in 1 CARTON (68083-490-01) / 10 mL in 1 BOTTLE	1 bottle	2022-09-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dorzolamide Hydrochloride and Timolol Maleate	Gland Pharma Limited	2024-05-14	Human Prescription Drug Label	6