FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Dorzolamide HCl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DORZOLAMIDE HYDROCHLORIDE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQZO5366EW7
Rxcui310015

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 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

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