Cyclogyl
CYCLOGYL (cyclopentolate hydrochloride ophthalmic solution, USP)
Approved
Approval ID
1d008c76-7210-4ace-90fa-7cd22762e12e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2023
Manufacturers
FDA
Alcon Laboratories, Inc.
DUNS: 008018525
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
cyclopentolate hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0065-0397
Application NumberANDA084108
Product Classification
M
Marketing Category
C73584
G
Generic Name
cyclopentolate hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateDecember 14, 2023
FDA Product Classification
INGREDIENTS (7)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CYCLOPENTOLATE HYDROCHLORIDEActive
Quantity: 20 mg in 1 mL
Code: 736I6971TE
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
cyclopentolate hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0065-0395
Application NumberANDA084109
Product Classification
M
Marketing Category
C73584
G
Generic Name
cyclopentolate hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateDecember 14, 2023
FDA Product Classification
INGREDIENTS (8)
CYCLOPENTOLATE HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: 736I6971TE
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
cyclopentolate hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0065-0396
Application NumberANDA084110
Product Classification
M
Marketing Category
C73584
G
Generic Name
cyclopentolate hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateDecember 14, 2023
FDA Product Classification
INGREDIENTS (8)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
CYCLOPENTOLATE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: 736I6971TE
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT