42195-128 : Ciprofloxacin and Fluocinolone Acetonide Auricular (Otic) Solution

Labeler: Xspire Pharma, LLC
Product Type: Human Prescription Drug
Drug Name:  Ciprofloxacin and Fluocinolone Acetonide
Dosage Form: Auricular (Otic) Solution
Application #: NDA208251
Rev. Date: 

NDC Package Codes:

  • 42195-128-14: 1 POUCH IN 1 CARTON (42195‑128‑14) > 14 VIAL, SINGLE‑DOSE IN 1 POUCH > .25 ML IN 1 VIAL, SINGLE‑DOSE

Active Ingredients:

  • Ciprofloxacin
  • Fluocinolone Acetonide

Dosage Strength:

  • .75 mg/.25mL
  • .0625 mg/.25mL

Pharmaceutical Classes:

  • Corticosteroid Hormone Receptor Agonists [MoA]
  • Corticosteroid [EPC]
  • Quinolone Antimicrobial [EPC]
  • Quinolones [CS]

Related Products:

Based on records with the same trade name.
  • 52536-080 Ciprofloxacin and Fluocinolone Acetonide Auricular (Otic) Solution by Wilshire Pharmaceuticals


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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.