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Dorzolamide hydrochloride

Dorzolamide hydrochloride Ophthalmic Solution

Approved
Approval ID

751ced94-0ba7-46d8-b560-b9de57802284

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 15, 2019

Manufacturers
FDA

FDC Limited

DUNS: 650441301

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Dorzolamide hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55545-1008
Application NumberANDA205294
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dorzolamide hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateNovember 15, 2019
FDA Product Classification

INGREDIENTS (8)

MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)Inactive
Code: ZYD53NBL45
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
DORZOLAMIDE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: QZO5366EW7
Classification: ACTIM

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Dorzolamide hydrochloride - FDA Drug Approval Details