Fluocinolone Acetonide is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by G&w Laboratories, Inc.. The primary component is Fluocinolone Acetonide.
| Product ID | 0713-0324_93c16f2e-294c-1605-b02d-2b385c17cea0 |
| NDC | 0713-0324 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Fluocinolone Acetonide |
| Generic Name | Fluocinolone Acetonide |
| Dosage Form | Cream |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2013-12-20 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA089525 |
| Labeler Name | G&W Laboratories, Inc. |
| Substance Name | FLUOCINOLONE ACETONIDE |
| Active Ingredient Strength | 0 mg/g |
| Pharm Classes | Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2013-12-20 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA012787 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2013-12-20 |
| Marketing End Date | 2020-02-29 |
| Marketing Category | NDA |
| Application Number | NDA012787 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | GM |
| Marketing Start Date | 2013-12-20 |
| Marketing End Date | 2020-09-30 |
| Ingredient | Strength |
|---|---|
| FLUOCINOLONE ACETONIDE | .25 mg/g |
| SPL SET ID: | 366b294a-a842-041d-b843-3c6b39f2213b |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 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 |
| 68462-185 | fluocinolone acetonide | fluocinolone acetonide |
| 68462-591 | FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE |
| 68462-590 | FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE |
| 71428-002 | Fluocinolone Acetonide | Fluocinolone Acetonide |
| 45802-485 | Fluocinolone acetonide | Fluocinolone acetonide |
| 45802-887 | fluocinolone acetonide | fluocinolone acetonide |
| 45802-009 | Fluocinolone Acetonide | Fluocinolone Acetonide |
| 51672-1365 | Fluocinolone Acetonide | Fluocinolone Acetonide |
| 51672-1356 | Fluocinolone Acetonide | Fluocinolone Acetonide |
| 51672-1357 | Fluocinolone Acetonide | Fluocinolone Acetonide |
| 52565-012 | Fluocinolone Acetonide | Fluocinolone Acetonide |
| 52565-020 | Fluocinolone Acetonide | Fluocinolone Acetonide |
| 52565-013 | Fluocinolone Acetonide | Fluocinolone Acetonide |
| 52565-031 | Fluocinolone Acetonide | Fluocinolone Acetonide |
| 61748-204 | Fluocinolone Acetonide | Fluocinolone Acetonide |
| 61748-250 | Fluocinolone Acetonide | Fluocinolone Acetonide |
| 65162-702 | Fluocinolone Acetonide | Fluocinolone Acetonide |
| 65162-704 | Fluocinolone Acetonide | Fluocinolone Acetonide |
| 65162-703 | Fluocinolone Acetonide | Fluocinolone Acetonide |
| 0299-5500 | Capex | fluocinolone acetonide |
| 39328-079 | Flac Otic Oil | fluocinolone acetonide |
| 13925-508 | Fluocinolone acetonide 0.01% | 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 |