Fluocinonide
- Product NDC
- 71656-094
- 11-digit product format
- 716560094
- Labeler code
- 71656
- Product ID
- 71656-094_518fd6ee-8b48-28ae-e063-6394a90a1303
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluocinonide
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Saptalis Pharmaceuticals, LLC.
- Application
- ANDA207554
- Marketing category
- ANDA
- Marketing start
- 2026-05-11
- Substance
- FLUOCINONIDE
- Active strength
- .5 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
- Fluocinonide
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUOCINONIDE | .5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2W4A77YPAN |
| Rxcui | 310364 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71656-094-20 | Fluocinonide | 20 mL in 1 BOTTLE | SOLUTION | 20 | | 2 |
| 71656-094-60 | Fluocinonide | 60 mL in 1 BOTTLE | SOLUTION | 60 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71656-094-20 | 71656009420 | 20 mL in 1 BOTTLE (71656-094-20) | 20 ml | 2026-05-11 | No | No | Current |
| 71656-094-60 | 71656009460 | 60 mL in 1 BOTTLE (71656-094-60) | 60 ml | 2026-05-11 | No | No | Current |