Fluocinolone acetonide 0.01% is a Auricular (otic) Oil in the Human Prescription Drug category. It is labeled and distributed by Seton Pharmaceuticals. The primary component is Fluocinolone Acetonide.
| Product ID | 13925-508_dfb898fc-1e28-4c46-ab2e-16139107ac4f |
| NDC | 13925-508 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Fluocinolone acetonide 0.01% |
| Generic Name | Fluocinolone Acetonide |
| Dosage Form | Oil |
| Route of Administration | AURICULAR (OTIC) |
| Marketing Start Date | 2013-08-01 |
| Marketing Category | NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC |
| Application Number | NDA019452 |
| Labeler Name | Seton Pharmaceuticals |
| Substance Name | FLUOCINOLONE ACETONIDE |
| Active Ingredient Strength | 0 mg/mL |
| Pharm Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2013-08-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA authorized generic |
| Application Number | NDA019452 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2013-08-01 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| FLUOCINOLONE ACETONIDE | .11 mg/mL |
| SPL SET ID: | be70a464-f936-4721-8cbb-b106075bfd4d |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 13925-508 | Fluocinolone acetonide 0.01% | fluocinolone acetonide |
| 0299-5500 | Capex | fluocinolone acetonide |
| 39328-079 | Flac Otic Oil | fluocinolone acetonide |
| 0168-0058 | Fluocinolone Acetonide | fluocinolone acetonide |
| 0168-0059 | Fluocinolone Acetonide | fluocinolone acetonide |
| 0168-0060 | Fluocinolone Acetonide | fluocinolone acetonide |
| 0168-0064 | Fluocinolone Acetonide | fluocinolone acetonide |
| 0713-0223 | Fluocinolone Acetonide | Fluocinolone Acetonide |
| 0713-0224 | Fluocinolone Acetonide | Fluocinolone Acetonide |
| 0713-0324 | Fluocinolone Acetonide | Fluocinolone Acetonide |
| 0713-0325 | Fluocinolone Acetonide | Fluocinolone Acetonide |
| 0713-0709 | FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE |
| 10135-670 | fluocinolone acetonide | fluocinolone acetonide |
| 13925-506 | Fluocinolone Acetonide | fluocinolone acetonide |
| 13925-507 | Fluocinolone Acetonide | fluocinolone acetonide |
| 42291-283 | Fluocinolone Acetonide | Fluocinolone Acetonide |
| 42291-284 | Fluocinolone Acetonide | Fluocinolone Acetonide |
| 42291-285 | Fluocinolone Acetonide | Fluocinolone Acetonide |
| 43386-069 | Fluocinolone Acetonide | Fluocinolone Acetonide |
| 24208-416 | Retisert | Fluocinolone Acetonide |
| 43538-900 | Synalar | fluocinolone acetonide |
| 43538-901 | Synalar | Fluocinolone acetonide |
| 43538-910 | Synalar | fluocinolone acetonide |
| 43538-911 | Synalar | Fluocinolone acetonide |
| 43538-920 | Synalar | fluocinolone acetonide |
| 43538-921 | Synalar TS | fluocinolone acetonide |