CIPROFLOXACIN HYDROCHLORIDE
0.3% as baseSterile
Approved
Approval ID
11f56251-d913-4986-9dba-c2e4df8a3822
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 11, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CIPROFLOXACIN HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-421
Application NumberNDA019992
Product Classification
M
Marketing Category
C73605
G
Generic Name
CIPROFLOXACIN HYDROCHLORIDE
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 11, 2012
FDA Product Classification
INGREDIENTS (9)
CIPROFLOXACIN HYDROCHLORIDEActive
Quantity: 3.5 mg in 1 mL
Code: 4BA73M5E37
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT