Cyclopentolate Hydrochloride
Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1% (Sterile)
Approved
Approval ID
0504a84a-0ba4-483b-9682-9bf3818410ee
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 6, 2013
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
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 Code54868-4697
Application NumberANDA040075
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclopentolate Hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateFebruary 6, 2013
FDA Product Classification
INGREDIENTS (8)
CYCLOPENTOLATE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: 736I6971TE
Classification: ACTIB
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT