NDC 42195-128

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 Xspire Pharma, Llc. The primary component is Ciprofloxacin; Fluocinolone Acetonide.

Product ID42195-128_575a0d84-f871-4823-a21b-f439f5fd3802
NDC42195-128
Product TypeHuman Prescription Drug
Proprietary NameCiprofloxacin and Fluocinolone Acetonide
Generic NameCiprofloxacin And Fluocinolone Acetonide
Dosage FormSolution
Route of AdministrationAURICULAR (OTIC)
Marketing Start Date2021-10-04
Marketing CategoryNDA /
Application NumberNDA208251
Labeler NameXspire Pharma, LLC
Substance NameCIPROFLOXACIN; FLUOCINOLONE ACETONIDE
Active Ingredient Strength1 mg/.25mL; mg/.25mL
Pharm ClassesCorticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 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
Marketing Start Date2021-10-04
NDC Exclude FlagN
Sample Package?N

Drug Details

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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