NDC 52536-080

Ciprofloxacin and Fluocinolone Acetonide

Ciprofloxacin And Fluocinolone Acetonide

Ciprofloxacin and Fluocinolone Acetonide is a Auricular (otic) Solution in the Human Prescription Drug category. It is labeled and distributed by Wilshire Pharmaceuticals. The primary component is Ciprofloxacin; Fluocinolone Acetonide.

Product ID52536-080_902d710e-3983-4f9b-b8eb-4a990bc4efa8
NDC52536-080
Product TypeHuman Prescription Drug
Proprietary NameCiprofloxacin and Fluocinolone Acetonide
Generic NameCiprofloxacin And Fluocinolone Acetonide
Dosage FormSolution
Route of AdministrationAURICULAR (OTIC)
Marketing Start Date2019-11-01
Marketing CategoryNDA / NDA
Application NumberNDA208251
Labeler NameWilshire Pharmaceuticals
Substance NameCIPROFLOXACIN; FLUOCINOLONE ACETONIDE
Active Ingredient Strength1 mg/.25mL; mg/.25mL
Pharm ClassesQuinolone Antimicrobial [EPC],Quinolones [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52536-080-14

1 POUCH in 1 CARTON (52536-080-14) > 14 VIAL, SINGLE-DOSE in 1 POUCH > .25 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2019-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52536-080-14 [52536008014]

Ciprofloxacin and Fluocinolone Acetonide SOLUTION
Marketing CategoryNDA
Application NumberNDA208251
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-11-01

Drug Details

Active Ingredients

IngredientStrength
CIPROFLOXACIN.75 mg/.25mL

Pharmacological Class

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

NDC Crossover Matching brand name "Ciprofloxacin and Fluocinolone Acetonide" or generic name "Ciprofloxacin And Fluocinolone Acetonide"

NDCBrand NameGeneric Name
42195-128Ciprofloxacin and Fluocinolone Acetonideciprofloxacin and fluocinolone acetonide
52536-080Ciprofloxacin and Fluocinolone Acetonideciprofloxacin and fluocinolone acetonide
66992-128OTOVELciprofloxacin and fluocinolone acetonide

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