ciprofloxacin

FDA Drug Profile — ciprofloxacin, Ciprofloxacin, Cipro, Ciprofloxacin in Dextrose

ciprofloxacin is listed in the FDA National Drug Code directory with 37 NDC codes, marketed under brand names including ciprofloxacin, Ciprofloxacin, Cipro. Available dosage forms: tablet, tablet, film coated, kit, injection, solution.

Drug Details

Generic Name
ciprofloxacin
Brand Names
ciprofloxacin, Ciprofloxacin, Cipro, Ciprofloxacin in Dextrose
Application Number
ANDA076639
Sponsor
NuCare Pharmaceuticals,Inc.
NDC Codes
37
Dosage Forms
TABLET, TABLET, FILM COATED, KIT, INJECTION, SOLUTION
Routes
ORAL, INTRAVENOUS
Active Ingredients
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN

Indications and Usage

1 INDICATIONS AND USAGE Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis , and Pseudomonas aeruginosa. Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult, and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa . Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension is a combination of ciprofloxacin, a fluoroquinolone antibacterial and dexamethasone, a corticosteroid, indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: • Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis , and Pseudomonas aeruginosa. ( 1 ) • Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa . ( 1 )