Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution

Product NDC: 46708-553
11-digit product format: 467080553
Labeler code: 46708
Product ID: 46708-553_2b1fa44a-3890-4634-bcfc-c7310b51128e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA213099
Marketing category: ANDA
Marketing start: 2021-05-04
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 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
A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1		2021-05-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213099-001	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
2026-02-19 14:30 UTC	2026-02	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2021-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2021-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2021-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2021-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2021-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2021-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2021-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2021-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2021-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2021-05-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2021-05-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2021-05-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2021-05-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2021-05-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2021-05-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2021-05-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2021-05-04	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2021-05-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2021-05-04	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2021-05-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2021-05-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2021-05-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2021-05-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2021-05-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2021-05-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2021-05-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2021-05-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2021-05-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2021-05-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2021-05-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2021-05-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2021-05-04	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213099-001	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2021-05-04	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213099-001	AT1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213099-001	AT1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213099-001	AT1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213099-001	AT1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213099-001	AT1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213099-001	AT1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213099-001	AT1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213099-001	AT1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213099-001	AT1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213099-001	AT1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213099-001	AT1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213099-001	AT1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213099-001	AT1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213099-001	AT1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213099-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213099-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213099-001	AT	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213099-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213099-001	AT	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213099-001	AT1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213099-001	AT1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213099-001	AT1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213099-001	AT1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213099-001	AT1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213099-001	AT1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213099-001	AT1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213099-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213099-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213099-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213099-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213099-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213099-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213099-001	AT1	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution
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
2b1fa44a-3890-4634-bcfc-c7310b51128e	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
46708-553-10	Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution	10 mL in 1 BOTTLE	SOLUTION/ DROPS	10		1
46708-553-10	Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution	1 in 1 CARTON	SOLUTION/ DROPS	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-553	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS LIMITED]	1	Current NDC, 2 package rows	20241107_2b1fa44a-3890-4634-bcfc-c7310b51128e.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 Hydrochloride and Timolol Maleate Ophthalmic Solution	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION	Alembic Pharmaceuticals Limited	2b1fa44a-3890-4634-bcfc-c7310b51128e	2024-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213099 application number: ANDA213099 ndc (product): 46708-553
Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION	Alembic Pharmaceuticals Inc.	6b9c446e-7068-479b-8611-aead7a8d2f50	2024-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213099 application number: ANDA213099

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	2b1fa44a-3890-4634-bcfc-c7310b51128e	1
1923432	dorzolamide 20 MG/ML / timolol 5 MG/ML Ophthalmic Solution	SCD	2b1fa44a-3890-4634-bcfc-c7310b51128e	1
1923432	dorzolamide 2 % / timolol 0.5 % Ophthalmic Solution	SY	2b1fa44a-3890-4634-bcfc-c7310b51128e	1
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	2b1fa44a-3890-4634-bcfc-c7310b51128e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
46708-553-10	46708055310	1 BOTTLE in 1 CARTON (46708-553-10) / 10 mL in 1 BOTTLE	1 bottle	2021-05-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution	Alembic Pharmaceuticals Limited \| Alembic Pharmaceuticals Limited (F3)	2024-11-06	Human Prescription Drug Label	1