Dorzolamide HCl

Product NDC
24208-485
11-digit product format
242080485
Labeler code
24208
Product ID
24208-485_f36cf152-efdb-424c-8669-34f0f76625eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dorzolamide HCl
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
ANDA090143
Marketing category
ANDA
Marketing start
2009-06-25
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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090143-001DORZOLAMIDE HYDROCHLORIDEDORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090143-001AT

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-253f01610625f2…
2019-09-15 20:21 UTC2019-09A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090143-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2009-06-25cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090143-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090143-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090143-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090143-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090143-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090143-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090143-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090143-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090143-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090143-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090143-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090143-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090143-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090143-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090143-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090143-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090143-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090143-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090143-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090143-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090143-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A090143-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090143-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090143-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090143-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A090143-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090143-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090143-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090143-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090143-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090143-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090143-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090143-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090143-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090143-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090143-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090143-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090143-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090143-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090143-001AT1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Dorzolamide HCl
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DORZOLAMIDE HYDROCHLORIDE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QZO5366EW7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310015Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8417d162-65a1-4266-bca7-707af1193bf3Available on FDA.report

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
24208-485-10Dorzolamide HCl1 in 1 CARTONSOLUTION/ DROPS112
24208-485-10Dorzolamide HCl10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-485-10ML - Milliliter24208-4850d993aac-2d78-45f0-a9b7-099ee0a567b712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DORZOLAMIDE HYDROCHLORIDEACTIVE INGREDIENTQZO5366EW7DORZOLAMIDE HCL SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
DORZOLAMIDEACTIVE MOIETY9JDX055TW1DORZOLAMIDE HCL SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7DORZOLAMIDE HCL SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)INACTIVE INGREDIENTS38J6RZN16DORZOLAMIDE HCL SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
MANNITOLINACTIVE INGREDIENT3OWL53L36ADORZOLAMIDE HCL SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDORZOLAMIDE HCL SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KDORZOLAMIDE HCL SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
WATERINACTIVE INGREDIENT059QF0KO0RDORZOLAMIDE HCL SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5
DORZOLAMIDE HYDROCHLORIDEACTIVE INGREDIENTQZO5366EW7DORZOLAMIDE HCL SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
DORZOLAMIDEACTIVE MOIETY9JDX055TW1DORZOLAMIDE HCL SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7DORZOLAMIDE HCL SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)INACTIVE INGREDIENTS38J6RZN16DORZOLAMIDE HCL SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ADORZOLAMIDE HCL SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDORZOLAMIDE HCL SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KDORZOLAMIDE HCL SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RDORZOLAMIDE HCL SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-485DORZOLAMIDE HCL SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]12Current NDC, Legacy NDC, 2 package rows20230823_8417d162-65a1-4266-bca7-707af1193bf3.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dorzolamide HClDORZOLAMIDE HCLBausch & Lomb Incorporated8417d162-65a1-4266-bca7-707af1193bf32026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090143
application number: ANDA090143
ndc (product): 24208-485
Dorzolamide HClDORZOLAMIDE HCLA-S Medication Solutions91df460c-b896-4600-9d33-e499b49ba1b62024-11-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090143
application number: ANDA090143

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310015dorzolamide HCl 2 % Ophthalmic SolutionPSN8417d162-65a1-4266-bca7-707af1193bf312
310015dorzolamide 20 MG/ML Ophthalmic SolutionSCD8417d162-65a1-4266-bca7-707af1193bf312
310015dorzolamide 2 % Ophthalmic SolutionSY8417d162-65a1-4266-bca7-707af1193bf312
310015dorzolamide 20 MG/ML (as dorzolamide HCl 22.3 MG/ML) Ophthalmic SolutionSY8417d162-65a1-4266-bca7-707af1193bf312
310015dorzolamide HCl 2 % Ophthalmic SolutionPSN91df460c-b896-4600-9d33-e499b49ba1b69
310015dorzolamide 20 MG/ML Ophthalmic SolutionSCD91df460c-b896-4600-9d33-e499b49ba1b69
310015dorzolamide 2 % Ophthalmic SolutionSY91df460c-b896-4600-9d33-e499b49ba1b69
310015dorzolamide 20 MG/ML (as dorzolamide HCl 22.3 MG/ML) Ophthalmic SolutionSY91df460c-b896-4600-9d33-e499b49ba1b69
310015dorzolamide HCl 2 % Ophthalmic SolutionPSN45a7e3c2-8527-4447-90fe-07ce688f25d32
310015dorzolamide 20 MG/ML Ophthalmic SolutionSCD45a7e3c2-8527-4447-90fe-07ce688f25d32
310015dorzolamide 2 % Ophthalmic SolutionSY45a7e3c2-8527-4447-90fe-07ce688f25d32
310015dorzolamide 20 MG/ML (as dorzolamide HCl 22.3 MG/ML) Ophthalmic SolutionSY45a7e3c2-8527-4447-90fe-07ce688f25d32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24208-485-10242080485101 BOTTLE, DROPPER in 1 CARTON (24208-485-10) / 10 mL in 1 BOTTLE, DROPPER2009-06-250000-00-00NoNoCurrent