NDC 0078-0799


Ciprofloxacin And Dexamethasone

CIPRODEX is a Auricular (otic) Suspension/ Drops in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Ciprofloxacin Hydrochloride; Dexamethasone.

Product ID0078-0799_3e2cf3ea-a8f2-42e3-8424-9a6d6f0a4cb3
Product TypeHuman Prescription Drug
Proprietary NameCIPRODEX
Generic NameCiprofloxacin And Dexamethasone
Dosage FormSuspension/ Drops
Route of AdministrationAURICULAR (OTIC)
Marketing Start Date2020-07-28
Marketing CategoryNDA /
Application NumberNDA021537
Labeler NameNovartis Pharmaceuticals Corporation
Active Ingredient Strength3 mg/mL; mg/mL
Pharm ClassesCorticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31


NDC 0078-0799-75

1 BOTTLE in 1 CARTON (0078-0799-75) > 7.5 mL in 1 BOTTLE
Marketing Start Date2020-07-28
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "CIPRODEX" or generic name "Ciprofloxacin And Dexamethasone"

NDCBrand NameGeneric Name
0065-8533CIPRODEXciprofloxacin and dexamethasone
0078-0799CIPRODEXciprofloxacin and dexamethasone
21695-969CIPRODEXciprofloxacin and dexamethasone
68071-1629CIPRODEXciprofloxacin and dexamethasone
71205-309CIPRODEXciprofloxacin and dexamethasone

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.