DORZOLAMIDE HYDROCHLORIDE

Product NDC
72888-077
11-digit product format
728880077
Labeler code
72888
Product ID
72888-077_2f317fdd-3f6d-bc0e-e063-6294a90aa300
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dorzolamide hydrochloride
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Advagen Pharma Ltd.
Application
ANDA078395
Marketing category
ANDA
Marketing start
2024-12-23
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72888-077-15DORZOLAMIDE HYDROCHLORIDE10 mL in 1 BOTTLESOLUTION102
72888-077-15DORZOLAMIDE HYDROCHLORIDE1 in 1 CARTONSOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-077-15ML - Milliliter72888-077f56a0b90-b6f7-42ca-8d33-12c1cb1d7e9812025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-077DORZOLAMIDE HYDROCHLORIDE SOLUTION [ADVAGEN PHARMA LTD.]2Current NDC, 2 package rows20250302_ed9d1658-43cc-4c78-b3d8-e7d980a6b673.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310015dorzolamide HCl 2 % Ophthalmic SolutionPSNed9d1658-43cc-4c78-b3d8-e7d980a6b6732
310015dorzolamide 20 MG/ML Ophthalmic SolutionSCDed9d1658-43cc-4c78-b3d8-e7d980a6b6732
310015dorzolamide 2 % Ophthalmic SolutionSYed9d1658-43cc-4c78-b3d8-e7d980a6b6732
310015dorzolamide 20 MG/ML (as dorzolamide HCl 22.3 MG/ML) Ophthalmic SolutionSYed9d1658-43cc-4c78-b3d8-e7d980a6b6732

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72888-077-15728880077151 BOTTLE in 1 CARTON (72888-077-15) / 10 mL in 1 BOTTLE1 bottle2024-12-23NoNoHistorical