FDA.reportPublic FDA data

Dorzolamide Hydrochloride Ophthalmic

Product NDC
50090-4882
11-digit product format
500904882
Labeler code
50090
Product ID
50090-4882_20057f70-1994-43ac-b9f9-0dc7d27a6d6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dorzolamide Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
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
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
50090-4882-0Dorzolamide Hydrochloride Ophthalmic10 mL in 1 BOTTLESOLUTION/ DROPS107
50090-4882-0Dorzolamide Hydrochloride Ophthalmic1 in 1 CARTONSOLUTION/ DROPS17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4882-0ML - Milliliter50090-4882a5f67708-1297-4987-aafc-40ec0977b4ac12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4882DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC (DORZOLAMIDE HYDROCHLORIDE) SOLUTION/ DROPS [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 2 package rows20231216_fa4b8802-3271-48a4-8a91-229ebc72f570.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
50090-4882-0500904882001 BOTTLE in 1 CARTON (50090-4882-0) / 10 mL in 1 BOTTLE1 bottle2020-02-110000-00-00NoNoCurrent