NDC 66992-128
OTOVEL
Ciprofloxacin And Fluocinolone Acetonide
OTOVEL is a Auricular (otic) Solution in the Human Prescription Drug category. It is labeled and distributed by Wraser Llc. The primary component is Ciprofloxacin; Fluocinolone Acetonide.
| Product ID | 66992-128_1f604776-2e24-4326-8c16-9850737b105a |
| NDC | 66992-128 |
| Product Type | Human Prescription Drug |
| Proprietary Name | OTOVEL |
| Generic Name | Ciprofloxacin And Fluocinolone Acetonide |
| Dosage Form | Solution |
| Route of Administration | AURICULAR (OTIC) |
| Marketing Start Date | 2021-10-04 |
| Marketing Category | NDA / |
| Application Number | NDA208251 |
| Labeler Name | WraSer LLC |
| Substance Name | CIPROFLOXACIN; FLUOCINOLONE ACETONIDE |
| Active Ingredient Strength | 1 mg/.25mL; mg/.25mL |
| Pharm Classes | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Quinolone Antimicrobial [EPC], Quinolones [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
Packaging
NDC 66992-128-14
1 POUCH in 1 CARTON (66992-128-14) > 14 VIAL, SINGLE-DOSE in 1 POUCH > .25 mL in 1 VIAL, SINGLE-DOSE
| Marketing Start Date | 2021-10-04 |
| NDC Exclude Flag | N |
| Sample Package? | N |
Drug Details
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 |
| 42195-128 | Ciprofloxacin and Fluocinolone Acetonide | ciprofloxacin and fluocinolone acetonide |
| 52536-080 | Ciprofloxacin and Fluocinolone Acetonide | ciprofloxacin and fluocinolone acetonide |
Trademark Results [OTOVEL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OTOVEL 86875555 5381190 Live/Registered |
LABORATORIOS SALVAT, S.A. 2016-01-14 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.