FDA.reportPublic FDA data

Dorzolamide Hydrochloride

Product NDC
70069-501
11-digit product format
700690501
Labeler code
70069
Product ID
70069-501_599cbb55-78b6-467b-8762-fe20c11b013e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dorzolamide Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Somerset Therapeutics, LLC
Application
ANDA215004
Marketing category
ANDA
Marketing start
2025-02-12
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 Hydrochloride
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
70069-501-01Dorzolamide Hydrochloride10 mL in 1 BOTTLESOLUTION/ DROPS106
70069-501-01Dorzolamide Hydrochloride1 in 1 CARTONSOLUTION/ DROPS16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-501-01ML - Milliliter70069-50125a335b4-8707-4e0a-8d06-76f559b497b912025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-501DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SOMERSET THERAPEUTICS, LLC]6Current NDC, 2 package rows20250214_0832960f-0a6f-4fd1-bf55-be9bebde53bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310015dorzolamide HCl 2 % Ophthalmic SolutionPSN0832960f-0a6f-4fd1-bf55-be9bebde53bd6
310015dorzolamide 20 MG/ML Ophthalmic SolutionSCD0832960f-0a6f-4fd1-bf55-be9bebde53bd6
310015dorzolamide 2 % Ophthalmic SolutionSY0832960f-0a6f-4fd1-bf55-be9bebde53bd6
310015dorzolamide 20 MG/ML (as dorzolamide HCl 22.3 MG/ML) Ophthalmic SolutionSY0832960f-0a6f-4fd1-bf55-be9bebde53bd6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70069-501-01700690501011 BOTTLE in 1 CARTON (70069-501-01) / 10 mL in 1 BOTTLE1 bottle2025-02-12NoNoHistorical