ciprofloxacin
Ciprofloxacin ophthalmic solution USP0.3% as baseSterile
Approved
Approval ID
0e9e58a0-6572-43b0-8b2e-e56e6ae8f1bc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 8, 2018
Manufacturers
FDA
FDC Limited
DUNS: 650441301
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 Code55545-1011
Application NumberANDA077568
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciprofloxacin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 8, 2018
FDA Product Classification
INGREDIENTS (8)
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
CIPROFLOXACIN HYDROCHLORIDEActive
Quantity: 3 mg in 1 mL
Code: 4BA73M5E37
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM ACETATE ANHYDROUSInactive
Code: NVG71ZZ7P0
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT