Dorzolamide Hydrochloride

Product NDC
72266-197
11-digit product format
722660197
Labeler code
72266
Product ID
72266-197_3fb5657e-e6e3-066b-e063-6294a90a67ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dorzolamide Hydrochloride
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
FOSUN PHARMA USA INC
Application
ANDA215660
Marketing category
ANDA
Marketing start
2023-01-23
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
72266-197-01Dorzolamide Hydrochloride10 mL in 1 BOTTLESOLUTION105
72266-197-01Dorzolamide Hydrochloride1 in 1 CARTONSOLUTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72266-197-01ML - Milliliter72266-1970196f08f-1a28-4fd1-847b-8f8afbc93a4e12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72266-197DORZOLAMIDE HYDROCHLORIDE SOLUTION [FOSUN PHARMA USA INC]3Current NDC, 2 package rows20250112_ef173b63-499f-301b-e053-2995a90a4771.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310015dorzolamide HCl 2 % Ophthalmic SolutionPSNef173b63-499f-301b-e053-2995a90a47715
310015dorzolamide 20 MG/ML Ophthalmic SolutionSCDef173b63-499f-301b-e053-2995a90a47715
310015dorzolamide 2 % Ophthalmic SolutionSYef173b63-499f-301b-e053-2995a90a47715
310015dorzolamide 20 MG/ML (as dorzolamide HCl 22.3 MG/ML) Ophthalmic SolutionSYef173b63-499f-301b-e053-2995a90a47715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72266-197-01722660197011 BOTTLE in 1 CARTON (72266-197-01) / 10 mL in 1 BOTTLE1 bottle2023-01-23NoNoHistorical