Dorzolamide HCl

Product NDC
50090-2406
11-digit product format
500902406
Labeler code
50090
Product ID
50090-2406_40559c5f-6ed7-474b-8f3a-b8616251c685
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dorzolamide HCl
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2406-0Dorzolamide HCl10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS109
50090-2406-0Dorzolamide HCl1 in 1 CARTONSOLUTION/ DROPS19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2406-0ML - Milliliter50090-2406bc478b74-07b5-409a-9c69-b450182aab9b12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2406DORZOLAMIDE HCL SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 2 package rows20241113_91df460c-b896-4600-9d33-e499b49ba1b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-2406-0500902406001 BOTTLE, DROPPER in 1 CARTON (50090-2406-0) / 10 mL in 1 BOTTLE, DROPPER2016-05-18NoNoHistorical