ciprofloxacin
ciprofloxacin is listed in the FDA National Drug Code directory with 35 NDC codes, marketed under brand names including ciprofloxacin, Ciprofloxacin in Dextrose, Ciprofloxacin. Available dosage forms: tablet, injection, solution, tablet, film coated, kit.
Drug Details
- Generic Name
- ciprofloxacin
- Brand Names
- ciprofloxacin, Ciprofloxacin in Dextrose, Ciprofloxacin, Cipro
- Application Number
- ANDA076639
- Sponsor
- Umasuto, LLC
- NDC Codes
- 35
- Dosage Forms
- TABLET, INJECTION, SOLUTION, TABLET, FILM COATED, KIT
- 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 )