Ciprofloxacin and Fluocinolone Acetonide
These highlights do not include all the information needed to use Ciprofloxacin and Fluocinolone Acetonide Otic Solution safely and effectively. See full prescribing information for Ciprofloxacin and Fluocinolone Acetonide Otic Solution. Ciprofloxacin and Fluocinolone Acetonide otic solution Initial U.S. Approval: 2016
Approved
Approval ID
f7664db7-c1aa-4b40-8df8-9cc0b57825f6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 2, 2023
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 and fluocinolone acetonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42195-128
Application NumberNDA208251
Product Classification
M
Marketing Category
C73605
G
Generic Name
ciprofloxacin and fluocinolone acetonide
Product Specifications
Route of AdministrationAURICULAR (OTIC)
Effective DateFebruary 2, 2023
FDA Product Classification
INGREDIENTS (6)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
FLUOCINOLONE ACETONIDEActive
Quantity: 0.0625 mg in 0.25 mL
Code: 0CD5FD6S2M
Classification: ACTIB
CIPROFLOXACINActive
Quantity: 0.75 mg in 0.25 mL
Code: 5E8K9I0O4U
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT