DORZOLAMIDE HYDROCHLORIDE

Product NDC
61314-019
11-digit product format
613140019
Labeler code
61314
Product ID
61314-019_4737243f-53c2-4db6-9d7e-84e07e67f539
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
2027-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61314-01961314-019-05DDiscontinued by firm2026-10-27

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078981-001DORZOLAMIDE HYDROCHLORIDEDORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078981-001AT

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-13c2088c7a36db…
2026-09-14 22:38:342026-08A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-1384e616aacf4f…
2026-08-18 06:07:402026-07A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-133f01610625f2…
2019-09-15 20:21 UTC2019-09A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078981-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-04-133a93d1ddd44b…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A078981-001AT1c2088c7a36db…
2026-09-14 22:38:342026-08A078981-001AT184e616aacf4f…
2026-08-18 06:07:402026-07A078981-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078981-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078981-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078981-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078981-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078981-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078981-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078981-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078981-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078981-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078981-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078981-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078981-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078981-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078981-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078981-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078981-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078981-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078981-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078981-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078981-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078981-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A078981-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078981-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078981-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078981-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A078981-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078981-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078981-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078981-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078981-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078981-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078981-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078981-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078981-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A078981-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A078981-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078981-001AT13a93d1ddd44b…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
DORZOLAMIDE HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DORZOLAMIDE HYDROCHLORIDE20 mg/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
973dd458-49b1-1bb1-62c6-b37c4b15fe1fProduct name520251121
03f77cb2-b4ad-3c11-8781-787b5ece4291Product name320240507
97dad5a2-c524-a7b5-dede-82edefe9ce62Product name720220929
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61314-019-05DORZOLAMIDE HYDROCHLORIDE5 mL in 1 BOTTLESOLUTION/ DROPS515
61314-019-10DORZOLAMIDE HYDROCHLORIDE10 mL in 1 BOTTLESOLUTION/ DROPS1015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-019-10ML - Milliliter61314-01928707815-1adb-4b16-846c-9253d7d3fee712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DORZOLAMIDE HYDROCHLORIDEACTIVE INGREDIENTQZO5366EW7DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.]9
DORZOLAMIDEACTIVE MOIETY9JDX055TW1DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.]9
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.]9
Hydroxyethyl Cellulose (2000 Cps At 1%)INACTIVE INGREDIENTS38J6RZN16DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.]9
MANNITOLINACTIVE INGREDIENT3OWL53L36ADORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.]9
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.]9
Trisodium Citrate DihydrateINACTIVE INGREDIENTB22547B95KDORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.]9
WATERINACTIVE INGREDIENT059QF0KO0RDORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-019DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC]15Current NDC, Legacy NDC, 2 package rows20230211_29157995-fa61-4425-86a5-5bd0e4718cd8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310015dorzolamide HCl 2 % Ophthalmic SolutionPSN29157995-fa61-4425-86a5-5bd0e4718cd815
310015dorzolamide 20 MG/ML Ophthalmic SolutionSCD29157995-fa61-4425-86a5-5bd0e4718cd815
310015dorzolamide 2 % Ophthalmic SolutionSY29157995-fa61-4425-86a5-5bd0e4718cd815
310015dorzolamide 20 MG/ML (as dorzolamide HCl 22.3 MG/ML) Ophthalmic SolutionSY29157995-fa61-4425-86a5-5bd0e4718cd815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61314-019-05613140019055 mL in 1 BOTTLE5 mlHistorical
61314-019-10613140019101 BOTTLE in 1 CARTON (61314-019-10) / 10 mL in 1 BOTTLE1 bottle2009-06-010000-00-00NoNoCurrent