Fluocinolone Acetonide
- Product NDC
- 64980-331
- 11-digit product format
- 649800331
- Labeler code
- 64980
- Product ID
- 64980-331_f6254856-0b86-4d8d-9e92-66663f9f4d61
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluocinolone Acetonide
- Dosage form
- OIL
- Route
- TOPICAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA203377
- Marketing category
- ANDA
- Marketing start
- 2016-07-18
- Substance
- FLUOCINOLONE ACETONIDE
- Active strength
- .11 mg/mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluocinolone Acetonide
- Brand name suffix
- Oil
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUOCINOLONE ACETONIDE | .11 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0CD5FD6S2M |
| Rxcui | 1191307 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64980-331-04 | Fluocinolone AcetonideOil | 118.28 mL in 1 BOTTLE | OIL | 118.28 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64980-331 | FLUOCINOLONE ACETONIDE OIL (FLUOCINOLONE ACETONIDE) OIL [RISING PHARMA HOLDINGS, INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20250426_f45b0ef2-1702-4d21-8ac8-774769304595.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 |
|---|
| 64980-331-04 | 64980033104 | 118.28 mL in 1 BOTTLE (64980-331-04) | 118.28 ml | 2016-07-18 | 0000-00-00 | No | No | Current |