FDA.reportPublic FDA data

Dorzolamide Hydrochloride Ophthalmic Solution

Product NDC
42571-141
11-digit product format
425710141
Labeler code
42571
Product ID
42571-141_2b30c4d1-0a5d-3ad8-e063-6394a90a4acb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dorzolamide Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Micro Labs Limited
Application
ANDA204778
Marketing category
ANDA
Marketing start
2019-11-11
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 Ophthalmic Solution
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
42571-141-26Dorzolamide Hydrochloride Ophthalmic Solution1 in 1 CARTONSOLUTION/ DROPS19
42571-141-26Dorzolamide Hydrochloride Ophthalmic Solution10 mL in 1 BOTTLESOLUTION/ DROPS109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-141-26ML - Milliliter42571-141092e1bc1-98a0-4bc8-8947-74e0e12ea4b712019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-141DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION (DORZOLAMIDE HYDROCHLORIDE) SOLUTION/ DROPS [MICRO LABS LIMITED]9Current NDC, Legacy NDC, 2 package rows20250110_4698e4e1-c5f6-4db1-9328-74464a85afea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310015dorzolamide HCl 2 % Ophthalmic SolutionPSN4698e4e1-c5f6-4db1-9328-74464a85afea9
310015dorzolamide 20 MG/ML Ophthalmic SolutionSCD4698e4e1-c5f6-4db1-9328-74464a85afea9
310015dorzolamide 2 % Ophthalmic SolutionSY4698e4e1-c5f6-4db1-9328-74464a85afea9
310015dorzolamide 20 MG/ML (as dorzolamide HCl 22.3 MG/ML) Ophthalmic SolutionSY4698e4e1-c5f6-4db1-9328-74464a85afea9
310015dorzolamide HCl 2 % Ophthalmic SolutionPSNfa4b8802-3271-48a4-8a91-229ebc72f5707
310015dorzolamide 20 MG/ML Ophthalmic SolutionSCDfa4b8802-3271-48a4-8a91-229ebc72f5707
310015dorzolamide 2 % Ophthalmic SolutionSYfa4b8802-3271-48a4-8a91-229ebc72f5707
310015dorzolamide 20 MG/ML (as dorzolamide HCl 22.3 MG/ML) Ophthalmic SolutionSYfa4b8802-3271-48a4-8a91-229ebc72f5707

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-141-26425710141261 BOTTLE in 1 CARTON (42571-141-26) / 10 mL in 1 BOTTLE1 bottle2019-11-110000-00-00NoNoCurrent