Ciprofloxacin
Ciprofloxacin Ophthalmic Solution
Approved
Approval ID
5bc71138-98ef-49eb-822c-517550b397f8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2011
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ciprofloxacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-557
Application NumberANDA076673
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciprofloxacin
Product Specifications
Route of AdministrationOPHTHALMIC, TOPICAL
Effective DateDecember 21, 2011
FDA Product Classification
INGREDIENTS (9)
CIPROFLOXACIN HYDROCHLORIDEActive
Quantity: 3 mg in 1 mL
Code: 4BA73M5E37
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT