FDA.reportPublic FDA data

Dorzolamide Hydrochloride

Product NDC
72266-197
Requested package NDC
72266-197-01
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215660-001DORZOLAMIDE HYDROCHLORIDEDORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2022-01-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A215660-001AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A215660-001DORZOLAMIDE HYDROCHLORIDEEQ 2% BASESOLUTION/DROPS / OPHTHALMICAT2022-01-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A215660-001AT1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dorzolamide HydrochlorideDORZOLAMIDE HYDROCHLORIDESagent Pharmaceuticals0246463c-6c24-4611-8e22-2d5254ace66a2026-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215660
application number: ANDA215660
Dorzolamide HydrochlorideDORZOLAMIDE HYDROCHLORIDEFOSUN PHARMA USA INCef173b63-499f-301b-e053-2995a90a47712025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215660
application number: ANDA215660
ndc (package): 72266-197-01
ndc (product): 72266-197
ndc11 (package): 72266019701
Dorzolamide HydrochlorideDORZOLAMIDE HYDROCHLORIDEGland Pharma Limited2023e603-12bb-4502-9f93-0126e0cc24ed2025-05-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215660
application number: ANDA215660

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QZO5366EW7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310015Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ef173b63-499f-301b-e053-2995a90a4771Available on FDA.report

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 bottle2023-01-23NoNoCurrent