Cipro
Approved
Approval ID
14b45f78-0bc0-4e25-831e-d2a0006b2b87
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 hydrochloride, hydrocortisone and benzyl alcohol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4365
Application NumberNDA020805
Product Classification
M
Marketing Category
C73594
G
Generic Name
ciprofloxacin hydrochloride, hydrocortisone and benzyl alcohol
Product Specifications
Route of AdministrationAURICULAR (OTIC)
Effective DateDecember 13, 2010
FDA Product Classification
INGREDIENTS (9)
CIPROFLOXACIN HYDROCHLORIDEActive
Quantity: 2 mg in 1 mL
Code: 4BA73M5E37
Classification: ACTIB
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
BENZYL ALCOHOLActive
Quantity: 9 mg in 1 mL
Code: LKG8494WBH
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCORTISONEActive
Quantity: 10 mg in 1 mL
Code: WI4X0X7BPJ
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT