FLUOCINOLONE ACETONIDE
- Product NDC
- 65162-704
- 11-digit product format
- 651620704
- Labeler code
- 65162
- Product ID
- 65162-704_9e17d20a-5b7c-4905-94ad-1b07539477d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FLUOCINOLONE ACETONIDE
- Dosage form
- OIL
- Route
- TOPICAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA201764
- Marketing category
- ANDA
- Marketing start
- 2015-09-22
- Marketing end
- 0000-00-00
- Substance
- FLUOCINOLONE ACETONIDE
- Active strength
- 0 mg/118.28mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FLUOCINOLONE ACETONIDE | ACTIVE INGREDIENT | 0CD5FD6S2M | FLUOCINOLONE ACETONIDE OIL [AMNEAL PHARMACEUTICALS, LLC] | 10 | |
| FLUOCINOLONE ACETONIDE | ACTIVE MOIETY | 0CD5FD6S2M | FLUOCINOLONE ACETONIDE OIL [AMNEAL PHARMACEUTICALS, LLC] | 10 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | FLUOCINOLONE ACETONIDE OIL [AMNEAL PHARMACEUTICALS, LLC] | 10 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | FLUOCINOLONE ACETONIDE OIL [AMNEAL PHARMACEUTICALS, LLC] | 10 | |
| LIGHT MINERAL OIL | INACTIVE INGREDIENT | N6K5787QVP | FLUOCINOLONE ACETONIDE OIL [AMNEAL PHARMACEUTICALS, LLC] | 10 | |
| OLETH-2 | INACTIVE INGREDIENT | 7L6R1SQ6M0 | FLUOCINOLONE ACETONIDE OIL [AMNEAL PHARMACEUTICALS, LLC] | 10 | |
| PEANUT OIL | INACTIVE INGREDIENT | 5TL50QU0W4 | FLUOCINOLONE ACETONIDE OIL [AMNEAL PHARMACEUTICALS, LLC] | 10 | |
| FLUOCINOLONE ACETONIDE | ACTIVE INGREDIENT | 0CD5FD6S2M | FLUOCINOLONE ACETONIDE OIL [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| FLUOCINOLONE ACETONIDE | ACTIVE MOIETY | 0CD5FD6S2M | FLUOCINOLONE ACETONIDE OIL [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | FLUOCINOLONE ACETONIDE OIL [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | FLUOCINOLONE ACETONIDE OIL [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| LIGHT MINERAL OIL | INACTIVE INGREDIENT | N6K5787QVP | FLUOCINOLONE ACETONIDE OIL [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| OLETH-2 | INACTIVE INGREDIENT | 7L6R1SQ6M0 | FLUOCINOLONE ACETONIDE OIL [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| PEANUT OIL | INACTIVE INGREDIENT | 5TL50QU0W4 | FLUOCINOLONE ACETONIDE OIL [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-704 | FLUOCINOLONE ACETONIDE OIL [AMNEAL PHARMACEUTICALS LLC] | 15 | Legacy NDC | 20250523_64586ff9-941a-418a-a870-ffb5dafbe24b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65162-704-86 | 65162070486 | 1 BOTTLE in 1 CARTON (65162-704-86) > 118.28 mL in 1 BOTTLE | 1 bottle | 2015-09-22 | 0000-00-00 | No | No | Current |