CIPRODEX
These highlights do not include all the information needed to use CIPRODEX safely and effectively. See full prescribing information for CIPRODEX. CIPRODEX (ciprofloxacin and dexamethasone), otic suspensionInitial U.S. Approval: 2003
Approved
Approval ID
3e2cf3ea-a8f2-42e3-8424-9a6d6f0a4cb3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 26, 2023
Manufacturers
FDA
Novartis Pharmaceuticals Corporation
DUNS: 002147023
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ciprofloxacin and dexamethasone
PRODUCT DETAILS
NDC Product Code0078-0799
Application NumberNDA021537
Marketing CategoryC73594
Route of AdministrationAURICULAR (OTIC)
Effective DateApril 19, 2022
Generic Nameciprofloxacin and dexamethasone
INGREDIENTS (13)
Ciprofloxacin HydrochlorideActive
Quantity: 3 mg in 1 mL
Code: 4BA73M5E37
Classification: ACTIM
Boric AcidInactive
Code: R57ZHV85D4
Classification: IACT
DexamethasoneActive
Quantity: 1 mg in 1 mL
Code: 7S5I7G3JQL
Classification: ACTIB
Benzalkonium ChlorideInactive
Code: F5UM2KM3W7
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
TyloxapolInactive
Code: Y27PUL9H56
Classification: IACT
Hydroxyethyl Cellulose (1500 Mpa.s At 1%)Inactive
Code: L605B5892V
Classification: IACT
Sodium AcetateInactive
Code: 4550K0SC9B
Classification: IACT
Edetate DisodiumInactive
Code: 7FLD91C86K
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Acetic AcidInactive
Code: Q40Q9N063P
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT