FDA.reportPublic FDA data

Dorzolamide hydrochloride

Product NDC
69315-304
11-digit product format
693150304
Labeler code
69315
Product ID
69315-304_74ba8267-62eb-4b2e-a349-400d998a8eb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dorzolamide hydrochloride
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Leading Pharma, LLC
Application
ANDA205294
Marketing category
ANDA
Marketing start
2019-12-01
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
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69315-304-05Dorzolamide hydrochloride5 mL in 1 BOTTLESOLUTION55
69315-304-05Dorzolamide hydrochloride1 in 1 CARTONSOLUTION15
69315-304-10Dorzolamide hydrochloride1 in 1 CARTONSOLUTION15
69315-304-10Dorzolamide hydrochloride10 mL in 1 BOTTLESOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-304-10ML - Milliliter69315-304ab054f7e-3e51-4fbc-ba8c-ff7ef15b2e9712020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-304DORZOLAMIDE HYDROCHLORIDE SOLUTION [LEADING PHARMA, LLC]5Current NDC, Legacy NDC, 4 package rows20240526_7d4cb6cd-86d0-41d9-baa9-bca0fa7b0694.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310015dorzolamide HCl 2 % Ophthalmic SolutionPSN7d4cb6cd-86d0-41d9-baa9-bca0fa7b06945
310015dorzolamide 20 MG/ML Ophthalmic SolutionSCD7d4cb6cd-86d0-41d9-baa9-bca0fa7b06945
310015dorzolamide 2 % Ophthalmic SolutionSY7d4cb6cd-86d0-41d9-baa9-bca0fa7b06945
310015dorzolamide 20 MG/ML (as dorzolamide HCl 22.3 MG/ML) Ophthalmic SolutionSY7d4cb6cd-86d0-41d9-baa9-bca0fa7b06945

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69315-304-05693150304051 BOTTLE in 1 CARTON (69315-304-05) / 5 mL in 1 BOTTLE1 bottle2019-12-010000-00-00NoNoCurrent
69315-304-10693150304101 BOTTLE in 1 CARTON (69315-304-10) / 10 mL in 1 BOTTLE1 bottle2019-12-010000-00-00NoNoCurrent