Ciprofloxacin Otic
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CIPROFLOXACIN OTIC SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CIPROFLOXACIN OTIC SOLUTION. Ciprofloxacin Otic Solution, 0.2% Initial U.S. Approval: 1987
Approved
Approval ID
d0125acf-1879-452d-ba29-c0f753653789
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 30, 2021
Manufacturers
FDA
Xspire Pharma, Llc
DUNS: 078312042
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 Code42195-550
Application NumberNDA021918
Product Classification
M
Marketing Category
C73594
G
Generic Name
CIPROFLOXACIN
Product Specifications
Route of AdministrationAURICULAR (OTIC)
Effective DateOctober 28, 2019
FDA Product Classification
INGREDIENTS (4)
CIPROFLOXACIN HYDROCHLORIDEActive
Quantity: 0.5 mg in 0.25 mL
Code: 4BA73M5E37
Classification: ACTIM
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT