Dorzolamide Hydrochloride

Product NDC
62332-519
11-digit product format
623320519
Labeler code
62332
Product ID
62332-519_3072620e-aa7a-4213-bfe6-5a59de392798
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dorzolamide Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA212639
Marketing category
ANDA
Marketing start
2019-08-09
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
62332-519-10Dorzolamide Hydrochloride1 in 1 CARTONSOLUTION/ DROPS17
62332-519-10Dorzolamide Hydrochloride10 mL in 1 BOTTLESOLUTION/ DROPS107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-519-10ML - Milliliter62332-519039982f9-1fdc-46a9-8978-5d78f7be9b6912025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-519DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 2 package rows20240830_5ad43fd4-19f0-448f-97a8-625ada4cb147.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310015dorzolamide HCl 2 % Ophthalmic SolutionPSN5ad43fd4-19f0-448f-97a8-625ada4cb1477
310015dorzolamide 20 MG/ML Ophthalmic SolutionSCD5ad43fd4-19f0-448f-97a8-625ada4cb1477
310015dorzolamide 2 % Ophthalmic SolutionSY5ad43fd4-19f0-448f-97a8-625ada4cb1477
310015dorzolamide 20 MG/ML (as dorzolamide HCl 22.3 MG/ML) Ophthalmic SolutionSY5ad43fd4-19f0-448f-97a8-625ada4cb1477

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-519-10623320519101 BOTTLE in 1 CARTON (62332-519-10) / 10 mL in 1 BOTTLE1 bottle2019-08-090000-00-00NoNoCurrent