Azopt

Product NDC: 66758-085
11-digit product format: 667580085
Labeler code: 66758
Product ID: 66758-085_0afb6589-51ba-432c-aed1-20a12d5d3455
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: brinzolamide
Dosage form: SUSPENSION/ DROPS
Route: OPHTHALMIC
Labeler: Sandoz Inc
Application: NDA020816
Marketing category: NDA
Marketing start: 1998-04-30
Substance: BRINZOLAMIDE
Active strength: 10 mg/mL
Pharmacologic classes: Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA]
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 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
N020816-001	AZOPT	BRINZOLAMIDE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020816-001	AB

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1998-04-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1998-04-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1998-04-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1998-04-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1998-04-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020816-001	AZOPT	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-04-01	`e64feba35796…`

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	N020816-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020816-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020816-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020816-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020816-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020816-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020816-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020816-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020816-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020816-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020816-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020816-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020816-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020816-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020816-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020816-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020816-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020816-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N020816-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020816-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020816-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020816-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020816-001	AB	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020816-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020816-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020816-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020816-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020816-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020816-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020816-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020816-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020816-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020816-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020816-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020816-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020816-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020816-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Azopt
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BRINZOLAMIDE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9451Z89515	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
213272	Internal RxNorm lookup
308805	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
0afb6589-51ba-432c-aed1-20a12d5d3455	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d597d8a7-d57c-dd3a-cf57-7366f3edcf30	Product name	4	20240828
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
66758-085-70	Azopt	10 mL in 1 BOTTLE	SUSPENSION/ DROPS	10	1
66758-085-70	Azopt	1 in 1 CARTON	SUSPENSION/ DROPS	1	1
66758-085-85	Azopt	15 mL in 1 BOTTLE	SUSPENSION/ DROPS	15	1
66758-085-85	Azopt	1 in 1 CARTON	SUSPENSION/ DROPS	1	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66758-085-70	ML - Milliliter	66758-085	a60d88b4-12b4-4d80-8b2d-c67a1ce55035	1	2024-11-05
66758-085-85	ML - Milliliter	66758-085	cec40dca-d0aa-44ea-8218-d25ca2229505	1	2025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66758-085	AZOPT (BRINZOLAMIDE) SUSPENSION/ DROPS [SANDOZ INC]	1	Current NDC, 4 package rows	20241025_0afb6589-51ba-432c-aed1-20a12d5d3455.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
Azopt	BRINZOLAMIDE	Sandoz Inc	0afb6589-51ba-432c-aed1-20a12d5d3455	2023-11-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020816 application number: NDA020816 ndc (product): 66758-085
Brinzolamide	BRINZOLAMIDE	Sandoz Inc	ed6dbc25-47d7-42db-9787-5814d71f45ce	2023-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020816 application number: NDA020816

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9451Z89515	BRINZOLAMIDE	138890-62-7	BRINZOLAMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
213272	Azopt 1 % Ophthalmic Suspension	PSN	0afb6589-51ba-432c-aed1-20a12d5d3455	1
308805	brinzolamide 1 % Ophthalmic Suspension	PSN	0afb6589-51ba-432c-aed1-20a12d5d3455	1
213272	brinzolamide 10 MG/ML Ophthalmic Suspension [Azopt]	SBD	0afb6589-51ba-432c-aed1-20a12d5d3455	1
308805	brinzolamide 10 MG/ML Ophthalmic Suspension	SCD	0afb6589-51ba-432c-aed1-20a12d5d3455	1
213272	Azopt 1 % Ophthalmic Suspension	SY	0afb6589-51ba-432c-aed1-20a12d5d3455	1
213272	Azopt 10 MG/ML Ophthalmic Suspension	SY	0afb6589-51ba-432c-aed1-20a12d5d3455	1
308805	brinzolamide 1 % Ophthalmic Suspension	SY	0afb6589-51ba-432c-aed1-20a12d5d3455	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
66758-085-70	66758008570	1 BOTTLE in 1 CARTON (66758-085-70) / 10 mL in 1 BOTTLE	1 bottle	2024-10-25	No	No	Current
66758-085-85	66758008585	1 BOTTLE in 1 CARTON (66758-085-85) / 15 mL in 1 BOTTLE	1 bottle	2024-11-15	No	No	Current