CIPRODEX (Page 4 of 4)


NDC 71205-309-75
Rx Only
(ciprofloxacin 0.3% and dexamethasone 0.1%)
7.5 mL
a Novartis company

(click image for full-size original)
CIPRODEX ciprofloxacin and dexamethasone suspension/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71205-309(NDC:0065-8533)
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ciprofloxacin Hydrochloride (Ciprofloxacin) Ciprofloxacin 3 mg in 1 mL
Dexamethasone (Dexamethasone) Dexamethasone 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Benzalkonium Chloride
Boric Acid
Sodium Chloride
Hydroxyethyl Cellulose (1500 Mpa.s At 1%)
Acetic Acid
Sodium Acetate
Edetate Disodium
Sodium Hydroxide
Hydrochloric Acid
# Item Code Package Description Multilevel Packaging
1 NDC:71205-309-75 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 7.5 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (71205-309-75)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021537 08/04/2003
Labeler — Proficient Rx LP (079196022)
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (71205-309), RELABEL (71205-309)

Revised: 03/2020 Proficient Rx LP

Page 4 of 4 1 2 3 4

All resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.