Dorzolamide Hydrochloride

Product NDC: 70377-081
11-digit product format: 703770081
Labeler code: 70377
Product ID: 70377-081_56fdb140-a79c-468a-80b4-88e846618064
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dorzolamide
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Biocon Pharma Inc.
Application: ANDA202053
Marketing category: ANDA
Marketing start: 2022-01-08
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70377-081		I	Inactivated by FDA		2026-08-11
excluded package	package	70377-081	70377-081-11	I	Inactivated by FDA		2026-08-11

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
A202053-001	DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT		2014-09-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202053-001	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	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		2014-09-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		2014-09-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		2014-09-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		2014-09-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		2014-09-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		2014-09-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		2014-09-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		2014-09-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC		2014-09-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202053-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2014-09-11	`cb3db0bc1861…`

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	A202053-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202053-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202053-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202053-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202053-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202053-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202053-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202053-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202053-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202053-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202053-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202053-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202053-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202053-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202053-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202053-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202053-001	AT	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A202053-001	AT	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202053-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202053-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202053-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202053-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202053-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202053-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202053-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202053-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202053-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202053-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202053-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202053-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202053-001	AT	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A202053-001	AT	1	`a50c72e98297…`

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	Strength	SPL version
70377-081-11	Dorzolamide Hydrochloride	1 in 1 CARTON	SOLUTION/ DROPS	1		2
70377-081-11	Dorzolamide Hydrochloride	10 mL in 1 BOTTLE, DISPENSING	SOLUTION/ DROPS	10		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70377-081-11	ML - Milliliter	70377-081	03def2f6-d194-4a95-84fa-d8069a9a01d8	1	2022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70377-081	DORZOLAMIDE HYDROCHLORIDE (DORZOLAMIDE) SOLUTION/ DROPS [BIOCON PHARMA INC.]	2	Legacy NDC, 2 package rows	20220113_9bc35df4-2d41-4160-8dae-7eea3e4ff0ce.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 Ophthalmic	DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC	Florida Pharmaceutical Products, LLC	e4e6a5a8-f7be-4424-83f2-d6bb4d57443e	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202053 application number: ANDA202053
Dorzolamide Hydrochloride	DORZOLAMIDE	Indoco Remedies Limited	462a61b2-1ec6-4d18-bc6b-fc03e027caa0	2024-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202053 application number: ANDA202053

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QZO5366EW7	DORZOLAMIDE HYDROCHLORIDE	130693-82-2	DORZOLAMIDE HYDROCHLORIDE
9JDX055TW1	DORZOLAMIDE	120279-96-1	Dorzolamide

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310015	dorzolamide HCl 2 % Ophthalmic Solution	PSN	9bc35df4-2d41-4160-8dae-7eea3e4ff0ce	2
310015	dorzolamide 20 MG/ML Ophthalmic Solution	SCD	9bc35df4-2d41-4160-8dae-7eea3e4ff0ce	2
310015	dorzolamide 2 % Ophthalmic Solution	SY	9bc35df4-2d41-4160-8dae-7eea3e4ff0ce	2
310015	dorzolamide 20 MG/ML (as dorzolamide HCl 22.3 MG/ML) Ophthalmic Solution	SY	9bc35df4-2d41-4160-8dae-7eea3e4ff0ce	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70377-081-11	70377008111	1 BOTTLE, DISPENSING in 1 CARTON (70377-081-11) > 10 mL in 1 BOTTLE, DISPENSING	2022-01-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dorzolamide Hydrochloride	Biocon Pharma Inc. \| INDOCO REMEDIES LIMITED	2022-01-10	Human Prescription Drug Label	2