Dorzolamide Hydrochloride

Product NDC
50090-1246
11-digit product format
500901246
Labeler code
50090
Product ID
50090-1246_d60eb0bc-9eba-428e-a96d-e59cc69eca57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dorzolamide Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA077846
Marketing category
ANDA
Marketing start
2008-10-28
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
2022-12-31
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1246-0Dorzolamide Hydrochloride10 mL in 1 BOTTLESOLUTION/ DROPS1015
50090-1246-0Dorzolamide Hydrochloride1 in 1 CARTONSOLUTION/ DROPS115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1246-0ML - Milliliter50090-124656562e0e-b867-4324-be4c-4d44494a00c212018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1246DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]15Legacy NDC, 2 package rows20210416_657c5121-32e2-440a-ae04-0b43e87f9f77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310015dorzolamide HCl 2 % Ophthalmic SolutionPSN657c5121-32e2-440a-ae04-0b43e87f9f7715
310015dorzolamide 20 MG/ML Ophthalmic SolutionSCD657c5121-32e2-440a-ae04-0b43e87f9f7715
310015dorzolamide 2 % Ophthalmic SolutionSY657c5121-32e2-440a-ae04-0b43e87f9f7715
310015dorzolamide 20 MG/ML (as dorzolamide HCl 22.3 MG/ML) Ophthalmic SolutionSY657c5121-32e2-440a-ae04-0b43e87f9f7715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1246-0500901246001 BOTTLE in 1 CARTON (50090-1246-0) > 10 mL in 1 BOTTLE1 bottle2014-11-280000-00-00NoNoCurrent