FLUOCINOLONE ACETONIDE
- Product NDC
- 71335-2879
- 11-digit product format
- 713352879
- Labeler code
- 71335
- Product ID
- 71335-2879_0cd1128a-9159-4955-849b-054c9444ad0a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluocinolone acetonide
- Dosage form
- OIL
- Route
- AURICULAR (OTIC)
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA212762
- Marketing category
- ANDA
- Marketing start
- 2021-04-02
- Substance
- FLUOCINOLONE ACETONIDE
- Active strength
- .11 mg/mL
- 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 | .11 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0CD5FD6S2M |
| Rxcui | 1191299 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-2879-1 | FLUOCINOLONE ACETONIDE | 1 in 1 CARTON | OIL | 1 | | 100 |
| 71335-2879-1 | FLUOCINOLONE ACETONIDE | 20 mL in 1 BOTTLE | OIL | 20 | | 100 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2879-1 | 71335287901 | 1 BOTTLE in 1 CARTON (71335-2879-1) / 20 mL in 1 BOTTLE | 1 bottle | 2025-11-11 | No | No | Current |