DORZOLAMIDE HYDROCHLORIDE

Product NDC: 61314-019
11-digit product format: 613140019
Labeler code: 61314
Product ID: 61314-019_764fec18-11c4-4320-a834-83c80c7040d2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dorzolamide hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Sandoz Inc
Application: ANDA078981
Marketing category: ANDA
Marketing start: 2009-06-01
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: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61314-019	61314-019-05	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A078981-001	DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT		2009-04-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078981-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078981-001	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	2009-04-13	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078981-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078981-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078981-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078981-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078981-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078981-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078981-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078981-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078981-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078981-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078981-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078981-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078981-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078981-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078981-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078981-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078981-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078981-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078981-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078981-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078981-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078981-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078981-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078981-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078981-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078981-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078981-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078981-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078981-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078981-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078981-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078981-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078981-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078981-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078981-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078981-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078981-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078981-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078981-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078981-001	AT	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DORZOLAMIDE HYDROCHLORIDE	20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310015	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
29157995-fa61-4425-86a5-5bd0e4718cd8	Available on FDA.report

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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
61314-019-05	DORZOLAMIDE HYDROCHLORIDE	5 mL in 1 BOTTLE	SOLUTION/ DROPS	5		15
61314-019-10	DORZOLAMIDE HYDROCHLORIDE	10 mL in 1 BOTTLE	SOLUTION/ DROPS	10		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61314-019-10	ML - Milliliter	61314-019	28707815-1adb-4b16-846c-9253d7d3fee7	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DORZOLAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	QZO5366EW7	DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.]	9
DORZOLAMIDE	ACTIVE MOIETY	9JDX055TW1	DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.]	9
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.]	9
Hydroxyethyl Cellulose (2000 Cps At 1%)	INACTIVE INGREDIENT	S38J6RZN16	DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.]	9
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.]	9
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.]	9
Trisodium Citrate Dihydrate	INACTIVE INGREDIENT	B22547B95K	DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.]	9
WATER	INACTIVE INGREDIENT	059QF0KO0R	DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61314-019	DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC]	15	Current NDC, Legacy NDC, 2 package rows	20230211_29157995-fa61-4425-86a5-5bd0e4718cd8.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	Sandoz Inc	29157995-fa61-4425-86a5-5bd0e4718cd8	2022-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078981 application number: ANDA078981 ndc (product): 61314-019

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310015	dorzolamide HCl 2 % Ophthalmic Solution	PSN	29157995-fa61-4425-86a5-5bd0e4718cd8	15
310015	dorzolamide 20 MG/ML Ophthalmic Solution	SCD	29157995-fa61-4425-86a5-5bd0e4718cd8	15
310015	dorzolamide 2 % Ophthalmic Solution	SY	29157995-fa61-4425-86a5-5bd0e4718cd8	15
310015	dorzolamide 20 MG/ML (as dorzolamide HCl 22.3 MG/ML) Ophthalmic Solution	SY	29157995-fa61-4425-86a5-5bd0e4718cd8	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61314-019-05	61314001905	5 mL in 1 BOTTLE	5 ml					Historical
61314-019-10	61314001910	10 mL in 1 BOTTLE (61314-019-10)	10 ml	2009-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DORZOLAMIDE HYDROCHLORIDE	Sandoz Inc	2022-12-20	HUMAN PRESCRIPTION DRUG LABEL	15
DORZOLAMIDE HYDROCHLORIDE	A-S Medication Solutions	2021-04-15	HUMAN PRESCRIPTION DRUG LABEL	3