Prescription drug · NDA
Filsuvez (Birch triterpenes) NDC 10122-310
Birch triterpenes 100 mg/g · Gel · Topical · Chiesi USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10122-310-02 | 10122031002 | 1 TUBE in 1 CARTON (10122-310-02) / 23.4 g in 1 TUBE (10122-310-01)Marketed 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
- Chiesi USA, Inc.NDC labeler code 10122
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215064
- Marketing start
- Listing expires
- Identifiers
- Product ID 10122-310_14e5440b-aa04-4c95-92f6-c7f1ed9f7252SPL ID 14e5440b-aa04-4c95-92f6-c7f1ed9f7252SPL set ID 32ba9194-734c-47d4-84e1-b21e28a85ec5RxCUI 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
N410122031002followed by a unit qualifier and the quantityPackage 10122-0310-02. 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 10122-310
- What is NDC 10122-310?
- 10122-310 is the product NDC for Filsuvez (birch triterpenes), Birch triterpenes 100 mg/g gel, listed with the FDA by Chiesi USA, Inc.. 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?
- Chiesi USA, Inc., NDC labeler code 10122. 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 | Amryt Pharmaceuticals DAC | 76431-310 | 76431-0310-01 |
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 | Amryt Pharmaceuticals DAC | 76431-310 |