NDC 24338-080

OTOVEL

(ciprofloxacin And Fluocinolone Acetonide)

OTOVEL is a Auricular (otic) For Solution in the Human Prescription Drug category. It is labeled and distributed by Arbor Pharmaceuticals. The primary component is Ciprofloxacin; Fluocinolone Acetonide; Polysorbate 80.

• Product ID: 24338-080_736bbfd0-1fbd-4615-80f6-3f5f1ae12284
• NDC: 24338-080
• Product Type: Human Prescription Drug
• Proprietary Name: OTOVEL
• Generic Name: (ciprofloxacin And Fluocinolone Acetonide)
• Dosage Form: For Solution
• Route of Administration: AURICULAR (OTIC)
• Marketing Start Date: 2016-04-29
• Marketing Category: NDA / NDA
• Application Number: NDA208251
• Labeler Name: Arbor Pharmaceuticals
• Substance Name: CIPROFLOXACIN; FLUOCINOLONE ACETONIDE; POLYSORBATE 80
• Active Ingredient Strength: 873 ug/.25mL; ug/.25mL; ug/.25mL
• Pharm Classes: Quinolone Antimicrobial [EPC],Quinolones [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 24338-080-14

1 POUCH in 1 CARTON (24338-080-14) > 14 VIAL, SINGLE-DOSE in 1 POUCH > .25 mL in 1 VIAL, SINGLE-DOSE (24338-080-25)

• Marketing Start Date: 2016-04-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 24338-080-01 [24338008001]

OTOVEL SOLUTION

• Marketing Category: NDA
• Application Number: NDA208251
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-04-29
• Marketing End Date: 2019-10-17

NDC 24338-080-14 [24338008014]

OTOVEL SOLUTION

• Marketing Category: NDA
• Application Number: NDA208251
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-04-29

NDC 24338-080-25 [24338008025]

OTOVEL SOLUTION

• Marketing Category: NDA
• Application Number: NDA208251
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-10-17

Drug Details

Active Ingredients

Ingredient	Strength
CIPROFLOXACIN	872.5 ug/.25mL

OpenFDA Data

• SPL SET ID: 1a7e4806-3138-4b7a-b798-a99e163ee846
• Manufacturer:
  • Arbor Pharmaceuticals
• UNII:
  • 0CD5FD6S2M
  • 5E8K9I0O4U
  • 6OZP39ZG8H
• RxNorm Concept Unique ID - RxCUI:
  • 1792391
  • 1792386

Pharmacological Class

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

Medicade Reported Pricing

24338008014 OTOVEL 0.3%-0.025% EAR DROPS

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "OTOVEL" or generic name "(ciprofloxacin And Fluocinolone Acetonide)"

NDC	Brand Name	Generic Name
24338-080	OTOVEL	(ciprofloxacin and fluocinolone acetonide)
66992-128	OTOVEL	ciprofloxacin and fluocinolone acetonide