Cyclopentolate Hydrochloride
Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1% (Sterile)
Approved
Approval ID
4d4131f8-79d0-40a4-87e8-667fd2db8d7a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 25, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code42254-013
Application NumberANDA040075
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclopentolate Hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMay 12, 2010
FDA Product Classification
INGREDIENTS (8)
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
CYCLOPENTOLATE HYDROCHLORIDEActive
Quantity: 10 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
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT