Fluocinonide
- Product NDC
- 68788-8554
- 11-digit product format
- 687888554
- Labeler code
- 68788
- Product ID
- 68788-8554_39276733-703f-4d70-95ba-ddba22abb08d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluocinonide
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA075008
- Marketing category
- ANDA
- Marketing start
- 2023-11-20
- Substance
- FLUOCINONIDE
- Active strength
- .5 mg/g
- 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/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2W4A77YPAN |
| Rxcui | 103457 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8554-6 | Fluocinonide | 1 in 1 CARTON | OINTMENT | 1 | | 4 |
| 68788-8554-6 | Fluocinonide | 60 g in 1 TUBE | OINTMENT | 60 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8554 | FLUOCINONIDE OINTMENT [PREFERRED PHARMACEUTICALS INC.] | 3 | Current NDC, 2 package rows | 20250515_80b72854-3fae-4cc7-bc41-2bdeb3e2cbe1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8554-6 | 68788855406 | 1 TUBE in 1 CARTON (68788-8554-6) / 60 g in 1 TUBE | 1 tube | 2023-11-20 | No | No | Historical |