FILSUVEZ
- Product NDC
- 76431-310
- 11-digit product format
- 764310310
- Labeler code
- 76431
- Product ID
- 76431-310_59bc2507-59e9-48c0-8c87-f65bb0f32258
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- birch triterpenes
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Amryt Pharmaceuticals DAC
- Application
- NDA215064
- Marketing category
- NDA
- Marketing start
- 2024-02-22
- Marketing end
- 2028-06-01
- Substance
- BIRCH TRITERPENES
- Active strength
- 100 mg/g
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FILSUVEZ
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BIRCH TRITERPENES | 100 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | BX09B0RQR0 |
| Rxcui | 2675587, 2675592 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76431-310-01 | FILSUVEZ | 1 in 1 CARTON | GEL | 1 | | 9 |
| 76431-310-01 | FILSUVEZ | 23.4 g in 1 TUBE | GEL | 23.4 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76431-310 | FILSUVEZ (BIRCH TRITERPENES) GEL [AMRYT PHARMACEUTICALS DAC] | 8 | Current NDC, 2 package rows | 20240224_da793f2d-0a3d-4792-8c22-982f9f8cdd97.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 |
|---|
| 76431-310-01 | 76431031001 | 1 TUBE in 1 CARTON (76431-310-01) / 23.4 g in 1 TUBE | 1 tube | 2024-02-22 | 2028-06-01 | No | No | Historical |