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NDC 66992-0128-14 OTOVEL .75; .0625 mg/.25mL; mg/.25mL Details
OTOVEL .75; .0625 mg/.25mL; mg/.25mL
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 Information
| NDC | 66992-0128 |
|---|---|
| Product ID | 66992-128_cd9ca29d-6de4-5ed5-e053-2995a90acf32 |
| Associated GPIs | 87991002382025 |
| GCN Sequence Number | 076088 |
| GCN Sequence Number Description | ciprofloxacin HCl/fluocinolone VIAL 0.3-0.025% OTIC (EAR) |
| HIC3 | Q8F |
| HIC3 Description | OTIC PREPARATIONS,ANTI-INFLAMMATORY-ANTIBIOTICS |
| GCN | 41358 |
| HICL Sequence Number | 040806 |
| HICL Sequence Number Description | CIPROFLOXACIN HCL/FLUOCINOLONE ACETONIDE |
| Brand/Generic | Brand |
| Proprietary Name | OTOVEL |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ciprofloxacin and fluocinolone acetonide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | AURICULAR (OTIC) |
| Active Ingredient Strength | .75; .0625 |
| Active Ingredient Units | mg/.25mL; mg/.25mL |
| Substance Name | CIPROFLOXACIN; FLUOCINOLONE ACETONIDE |
| Labeler Name | WraSer, LLC |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Quinolone Antimicrobial [EPC], Quinolones [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA208251 |
| Listing Certified Through | 2022-12-31 |
Package
NDC 66992-0128-14 (66992012814)
| NDC Package Code | 66992-128-14 |
|---|---|
| Billing NDC | 66992012814 |
| Package | 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 |
| Pricing Information | N/A |