Dorzolamide hydrochloride

Product NDC: 55545-1008
11-digit product format: 555451008
Labeler code: 55545
Product ID: 55545-1008_97618f4f-5891-0f06-e053-2995a90a3122
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dorzolamide hydrochloride
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: FDC Limited
Application: ANDA205294
Marketing category: ANDA
Marketing start: 2019-11-16
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: 2020-12-31
Current FDA listing: Historical FDA.report record

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
A205294-001	DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT		2019-01-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205294-001	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	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205294-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2019-01-24	`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	A205294-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205294-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205294-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205294-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205294-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205294-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205294-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205294-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205294-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205294-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205294-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205294-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205294-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205294-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205294-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205294-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205294-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205294-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205294-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205294-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205294-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205294-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205294-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205294-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205294-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205294-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205294-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205294-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205294-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205294-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205294-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205294-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205294-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205294-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205294-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205294-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205294-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205294-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205294-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205294-001	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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55545-1008-1	Dorzolamide hydrochloride	5 mL in 1 BOTTLE	SOLUTION	5	2
55545-1008-1	Dorzolamide hydrochloride	1 in 1 CARTON	SOLUTION	1	2
55545-1008-2	Dorzolamide hydrochloride	10 mL in 1 BOTTLE	SOLUTION	10	2
55545-1008-2	Dorzolamide hydrochloride	1 in 1 CARTON	SOLUTION	1	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55545-1008	DORZOLAMIDE HYDROCHLORIDE SOLUTION [FDC LIMITED]	2	Legacy NDC, 4 package rows	20191116_751ced94-0ba7-46d8-b560-b9de57802284.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	DORZOLAMIDE HYDROCHLORIDE	Leading Pharma, LLC	7d4cb6cd-86d0-41d9-baa9-bca0fa7b0694	2024-05-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205294 application number: ANDA205294

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
55545-1008-1	55545100801	5 mL in 1 BOTTLE	5 ml	Historical
55545-1008-2	55545100802	10 mL in 1 BOTTLE	10 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dorzolamide hydrochloride Ophthalmic Solution	FDC Limited	2019-11-15	HUMAN PRESCRIPTION DRUG LABEL	2