FDA.reportPublic FDA data

Dorzolamide Hydrochloride

Product NDC
25021-006
11-digit product format
250210006
Labeler code
25021
Product ID
25021-006_1a198736-860b-4ea2-a5db-e6ca487441bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dorzolamide Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Sagent Pharmaceuticals
Application
ANDA215660
Marketing category
ANDA
Marketing start
2026-01-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dorzolamide Hydrochloride
Listing expiration
2027-12-31

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
25021-006-10Dorzolamide Hydrochloride1 in 1 CARTONSOLUTION/ DROPS11
25021-006-10Dorzolamide Hydrochloride10 mL in 1 BOTTLESOLUTION/ DROPS101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-006-10ML - Milliliter25021-00621185763-9faf-4ff9-ae3e-be1f602e5e1112026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310015dorzolamide HCl 2 % Ophthalmic SolutionPSN0246463c-6c24-4611-8e22-2d5254ace66a1
310015dorzolamide 20 MG/ML Ophthalmic SolutionSCD0246463c-6c24-4611-8e22-2d5254ace66a1
310015dorzolamide 2 % Ophthalmic SolutionSY0246463c-6c24-4611-8e22-2d5254ace66a1
310015dorzolamide 20 MG/ML (as dorzolamide HCl 22.3 MG/ML) Ophthalmic SolutionSY0246463c-6c24-4611-8e22-2d5254ace66a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-006-10250210006101 BOTTLE in 1 CARTON (25021-006-10) / 10 mL in 1 BOTTLE1 bottle2026-01-15NoNoHistorical