FDA.reportPublic FDA data

Dorzolamide HCl

Product NDC
50090-2768
11-digit product format
500902768
Labeler code
50090
Product ID
50090-2768_3b65791c-5c9c-40d9-98ed-c63353830785
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dorzolamide Hydrochloride
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA202053
Marketing category
ANDA
Marketing start
2015-02-17
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2768-02020-01-31C16284748780-19d75b9d0-516a-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DORZOLAMIDE HY DROCHLORIDE OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION . DORZOLAMIDE HYDROCHLORIDE ophthalmic solution 2% Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2768-0Dorzolamide HCl10 mL in 1 BOTTLE, DISPENSINGSOLUTION105
50090-2768-0Dorzolamide HCl1 in 1 CARTONSOLUTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2768DORZOLAMIDE HCL (DORZOLAMIDE HYDROCHLORIDE) SOLUTION [A-S MEDICATION SOLUTIONS]5Legacy NDC, 2 package rows20180331_3cc1a5a5-64fb-4102-b74e-b7ed93576c24.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310015dorzolamide HCl 2 % Ophthalmic SolutionPSN3cc1a5a5-64fb-4102-b74e-b7ed93576c245
310015dorzolamide 20 MG/ML Ophthalmic SolutionSCD3cc1a5a5-64fb-4102-b74e-b7ed93576c245
310015dorzolamide 2 % Ophthalmic SolutionSY3cc1a5a5-64fb-4102-b74e-b7ed93576c245
310015dorzolamide 20 MG/ML (as dorzolamide HCl 22.3 MG/ML) Ophthalmic SolutionSY3cc1a5a5-64fb-4102-b74e-b7ed93576c245

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50090-2768-05009027680010 mL in 1 BOTTLE, DISPENSING10 mlHistorical