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Cyclomydril

Cyclomydril (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) Sterile

Approved
Approval ID

8268b70f-3f10-48dd-bb24-baaeb27a1325

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 14, 2023

Manufacturers
FDA

Alcon Laboratories, Inc.

DUNS: 008018525

Products 1

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

cyclopentolate hydrochloride and phenylephrine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0065-0359
Application NumberANDA084300
Product Classification
M
Marketing Category
C73584
G
Generic Name
cyclopentolate hydrochloride and phenylephrine hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateDecember 14, 2023
FDA Product Classification

INGREDIENTS (8)

CYCLOPENTOLATE HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: 736I6971TE
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: 04JA59TNSJ
Classification: ACTIB

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Cyclomydril - FDA Drug Approval Details