Fluocinolone acetonide
- Product NDC
- 72162-1412
- 11-digit product format
- 721621412
- Labeler code
- 72162
- Product ID
- 72162-1412_18788998-75d3-4ca1-991e-af8d9c85e3bd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluocinolone acetonide
- Dosage form
- OIL
- Route
- TOPICAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202848
- Marketing category
- ANDA
- Marketing start
- 2017-06-14
- Substance
- FLUOCINOLONE ACETONIDE
- Active strength
- .01 mg/100mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluocinolone acetonide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUOCINOLONE ACETONIDE | .01 mg/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0CD5FD6S2M |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72162-1412-2 | Fluocinolone acetonide | 1 in 1 CARTON | OIL | 1 | | 101 |
| 72162-1412-2 | Fluocinolone acetonide | 118.28 mL in 1 BOTTLE | OIL | 118.28 | | 101 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72162-1412 | FLUOCINOLONE ACETONIDE OIL [BRYANT RANCH PREPACK] | 100 | Current NDC, 2 package rows | 20240315_f674a0c0-df04-47e8-8d3f-a370182a596a.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72162-1412-2 | 72162141202 | 1 BOTTLE in 1 CARTON (72162-1412-2) / 118.28 mL in 1 BOTTLE | 1 bottle | 2024-03-13 | No | No | Current |