Cyclopentolate Hydrochloride
Cyclopentolate Hydrochloride Ophthalmic Solution, USP -Sterile
Approved
Approval ID
c53c8090-921f-45c5-bcd1-ce156ae3bb28
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2020
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-3874
Application NumberANDA040164
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclopentolate Hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateSeptember 30, 2011
FDA Product Classification
INGREDIENTS (8)
benzalkonium chlorideInactive
Code: F5UM2KM3W7
Classification: IACT
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
CYCLOPENTOLATE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: 736I6971TE
Classification: ACTIB
sodium carbonateInactive
Code: 45P3261C7T
Classification: IACT
boric acidInactive
Code: R57ZHV85D4
Classification: IACT
potassium chlorideInactive
Code: 660YQ98I10
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT