FDA.reportPublic FDA data

Dorzolamide Hydrochloride

Product NDC
46708-519
11-digit product format
467080519
Labeler code
46708
Product ID
46708-519_64e77f0a-fff5-4e24-9af2-38a14b9a4ef9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dorzolamide Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Alembic Pharmaceuticals Limited
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
46708-519-10Dorzolamide Hydrochloride1 in 1 CARTONSOLUTION/ DROPS11
46708-519-10Dorzolamide Hydrochloride10 mL in 1 BOTTLESOLUTION/ DROPS101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-519DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 2 package rows20240830_fb2e0729-b0bc-4c3f-9961-8bb38f84a032.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310015dorzolamide HCl 2 % Ophthalmic SolutionPSNfb2e0729-b0bc-4c3f-9961-8bb38f84a0321
310015dorzolamide 20 MG/ML Ophthalmic SolutionSCDfb2e0729-b0bc-4c3f-9961-8bb38f84a0321
310015dorzolamide 2 % Ophthalmic SolutionSYfb2e0729-b0bc-4c3f-9961-8bb38f84a0321
310015dorzolamide 20 MG/ML (as dorzolamide HCl 22.3 MG/ML) Ophthalmic SolutionSYfb2e0729-b0bc-4c3f-9961-8bb38f84a0321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-519-10467080519101 BOTTLE in 1 CARTON (46708-519-10) / 10 mL in 1 BOTTLE1 bottle2019-08-09NoNoHistorical