Fluocinonide
- Product NDC
- 0713-0664
- 11-digit product format
- 007130664
- Labeler code
- 0713
- Product ID
- 0713-0664_0abbc18e-8f87-0e6b-e063-6294a90a3685
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluocinonide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Cosette Pharmaceuticals, Inc.
- Application
- ANDA074204
- Marketing category
- ANDA
- Marketing start
- 2016-03-21
- Substance
- FLUOCINONIDE
- Active strength
- .5 mg/g
- 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/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2W4A77YPAN |
| Rxcui | 1801283 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0713-0664 | FLUOCINONIDE CREAM [COSETTE PHARMACEUTICALS, INC.] | 5 | Current NDC, Legacy NDC, 6 package rows | 20231123_b28c444d-cb70-42c3-a437-c66ae961dbb4.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 |
|---|
| 0713-0664-15 | 00713066415 | 1 TUBE in 1 CARTON (0713-0664-15) / 15 g in 1 TUBE | 1 tube | 2018-10-09 | 0000-00-00 | No | No | Current |
| 0713-0664-31 | 00713066431 | 1 TUBE in 1 CARTON (0713-0664-31) / 30 g in 1 TUBE | 1 tube | 2018-10-09 | 0000-00-00 | No | No | Current |
| 0713-0664-60 | 00713066460 | 1 TUBE in 1 CARTON (0713-0664-60) / 60 g in 1 TUBE | 1 tube | 2018-10-09 | 0000-00-00 | No | No | Current |