FDA.reportPublic FDA data

Dorzolamide Hydrochloride

Product NDC
68083-489
11-digit product format
680830489
Labeler code
68083
Product ID
68083-489_97a5fb1e-bdb1-43f9-8419-4b12d36d429c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dorzolamide Hydrochloride
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Gland Pharma Limited
Application
ANDA215660
Marketing category
ANDA
Marketing start
2022-01-27
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

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

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
68083-489-01Dorzolamide Hydrochloride1 in 1 CARTONSOLUTION18
68083-489-01Dorzolamide Hydrochloride10 mL in 1 BOTTLESOLUTION108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-489DORZOLAMIDE HYDROCHLORIDE SOLUTION [GLAND PHARMA LIMITED]7Current NDC, Legacy NDC, 2 package rows20240430_2023e603-12bb-4502-9f93-0126e0cc24ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310015dorzolamide HCl 2 % Ophthalmic SolutionPSN2023e603-12bb-4502-9f93-0126e0cc24ed8
310015dorzolamide 20 MG/ML Ophthalmic SolutionSCD2023e603-12bb-4502-9f93-0126e0cc24ed8
310015dorzolamide 2 % Ophthalmic SolutionSY2023e603-12bb-4502-9f93-0126e0cc24ed8
310015dorzolamide 20 MG/ML (as dorzolamide HCl 22.3 MG/ML) Ophthalmic SolutionSY2023e603-12bb-4502-9f93-0126e0cc24ed8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68083-489-01680830489011 BOTTLE in 1 CARTON (68083-489-01) / 10 mL in 1 BOTTLE1 bottle2022-01-270000-00-00NoNoCurrent