Ciprofloxacin Hydrochloride
CIPROFLOXACIN HYDROCHLORIDE OPHTHALMIC SOLUTION0.3% as baseSterile
Approved
Approval ID
2ef01a91-e73e-46d6-a6f9-d7d6dae91ea2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 23, 2010
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.
ciprofloxacin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-259
Application NumberNDA019992
Product Classification
M
Marketing Category
C73594
G
Generic Name
ciprofloxacin hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateFebruary 29, 2008
FDA Product Classification
INGREDIENTS (7)
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
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
acetic acidInactive
Code: Q40Q9N063P
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT