Prescription drug · NDA
Filsuvez (Birch triterpenes) NDC 76431-310
Birch triterpenes 100 mg/g · Gel · Topical · Amryt Pharmaceuticals DAC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76431-310-01 | 7643103100176431031001 | 1 TUBE in 1 CARTON (76431-310-01) / 23.4 g in 1 TUBEMarketed from Feb 22, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Filsuvez
- Generic name (nonproprietary)
- birch triterpenes
- Active ingredients
- Birch triterpenes — 100 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Amryt Pharmaceuticals DACNDC labeler code 76431
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215064
- Marketing start
- Marketing end
- Identifiers
- Product ID 76431-310_59bc2507-59e9-48c0-8c87-f65bb0f32258SPL ID 59bc2507-59e9-48c0-8c87-f65bb0f32258SPL set ID da793f2d-0a3d-4792-8c22-982f9f8cdd97RxCUI 2675587, 2675592UNII BX09B0RQR0
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N476431031001followed by a unit qualifier and the quantityPackage 76431-0310-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
FILSUVEZ is indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in adult and pediatric patients 6 months of age and older. FILSUVEZ topical gel is indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa in adult and pediatric patients 6 months of age and older. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 76431-310
- What is NDC 76431-310?
- 76431-310 is the product NDC for Filsuvez (birch triterpenes), Birch triterpenes 100 mg/g gel, listed with the FDA by Amryt Pharmaceuticals DAC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Filsuvez (Birch triterpenes).
- What is the active ingredient?
- Birch triterpenes.
- Who is the labeler?
- Amryt Pharmaceuticals DAC, NDC labeler code 76431. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Filsuvez?
- 1 other product NDC are listed under this name. See all Filsuvez NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Filsuvez products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Filsuvezbirch triterpenes | Birch triterpenes 100 mg/g | GelTopical | Chiesi USA, Inc. | 10122-310 | 10122-0310-02 |
Other NDCs under NDA 215064
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Filsuvezbirch triterpenes | Birch triterpenes 100 mg/g | GelTopical | Chiesi USA, Inc. | 10122-310 |