DORZOLAMIDE HYDROCHLORIDE

Product NDC
61314-019
11-digit product format
613140019
Labeler code
61314
Product ID
61314-019_764fec18-11c4-4320-a834-83c80c7040d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dorzolamide hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Sandoz Inc
Application
ANDA078981
Marketing category
ANDA
Marketing start
2009-06-01
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61314-019-05DORZOLAMIDE HYDROCHLORIDE5 mL in 1 BOTTLESOLUTION/ DROPS515
61314-019-10DORZOLAMIDE HYDROCHLORIDE10 mL in 1 BOTTLESOLUTION/ DROPS1015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-019-10ML - Milliliter61314-01928707815-1adb-4b16-846c-9253d7d3fee712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DORZOLAMIDE HYDROCHLORIDEACTIVE INGREDIENTQZO5366EW7DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.]9
DORZOLAMIDEACTIVE MOIETY9JDX055TW1DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.]9
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.]9
Hydroxyethyl Cellulose (2000 Cps At 1%)INACTIVE INGREDIENTS38J6RZN16DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.]9
MANNITOLINACTIVE INGREDIENT3OWL53L36ADORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.]9
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.]9
Trisodium Citrate DihydrateINACTIVE INGREDIENTB22547B95KDORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.]9
WATERINACTIVE INGREDIENT059QF0KO0RDORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-019DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC]15Current NDC, Legacy NDC, 2 package rows20230211_29157995-fa61-4425-86a5-5bd0e4718cd8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310015dorzolamide HCl 2 % Ophthalmic SolutionPSN29157995-fa61-4425-86a5-5bd0e4718cd815
310015dorzolamide 20 MG/ML Ophthalmic SolutionSCD29157995-fa61-4425-86a5-5bd0e4718cd815
310015dorzolamide 2 % Ophthalmic SolutionSY29157995-fa61-4425-86a5-5bd0e4718cd815
310015dorzolamide 20 MG/ML (as dorzolamide HCl 22.3 MG/ML) Ophthalmic SolutionSY29157995-fa61-4425-86a5-5bd0e4718cd815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61314-019-05613140019055 mL in 1 BOTTLE5 mlHistorical
61314-019-106131400191010 mL in 1 BOTTLE (61314-019-10) 10 ml2009-06-010000-00-00NoNoCurrent