Ciprodex
Approved
Approval ID
3e64e493-ef35-43b9-b08c-3c30fe4a7164
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4928
Application NumberNDA021537
Product Classification
M
Marketing Category
C73594
G
Generic Name
ciprofloxacin and dexamethasone
Product Specifications
Route of AdministrationAURICULAR (OTIC)
Effective DateDecember 13, 2010
FDA Product Classification
INGREDIENTS (10)
CIPROFLOXACIN HYDROCHLORIDEActive
Quantity: 3 mg in 1 mL
Code: 4BA73M5E37
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Quantity: 0.1 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
DEXAMETHASONEActive
Quantity: 1 mg in 1 mL
Code: 7S5I7G3JQL
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT