Fluocinonide
- Product NDC
- 43386-026
- 11-digit product format
- 433860026
- Labeler code
- 43386
- Product ID
- 43386-026_465101b9-6374-4ce8-b64d-97e296f5c72a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluocinonide
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA206003
- Marketing category
- ANDA
- Marketing start
- 2017-07-21
- Substance
- FLUOCINONIDE
- Active strength
- .5 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
- Fluocinonide
- Listing expiration
- 2026-12-31
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 |
|---|
| 43386-026-02 | Fluocinonide | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
| 43386-026-02 | Fluocinonide | 20 mL in 1 BOTTLE | SOLUTION | 20 | | 1 |
| 43386-026-06 | Fluocinonide | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
| 43386-026-06 | Fluocinonide | 60 mL in 1 BOTTLE | SOLUTION | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43386-026 | FLUOCINONIDE SOLUTION [LUPIN PHARMACEUTICALS,INC.] | 1 | Current NDC, Legacy NDC, 4 package rows | 20181221_43b7621c-6628-4b54-af32-32efd0f722da.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 |
|---|
| 43386-026-02 | 43386002602 | 1 BOTTLE in 1 CARTON (43386-026-02) / 20 mL in 1 BOTTLE | 1 bottle | 2017-07-21 | 0000-00-00 | No | No | Current |
| 43386-026-06 | 43386002606 | 1 BOTTLE in 1 CARTON (43386-026-06) / 60 mL in 1 BOTTLE | 1 bottle | 2017-07-21 | 0000-00-00 | No | No | Current |