Prescription drug · BLA
Vyjuvek NDC 82194-510
Kit · Krystal Biotech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82194-510-02 | 82194051002 | 1 KIT in 1 CARTON (82194-510-02) * 1 mL in 1 VIAL (82194-501-01) * 1.5 mL in 1 VIAL (82194-001-01)Marketed from May 19, 2023 |
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)
- Vyjuvek
- Generic name (nonproprietary)
- vyjuvek
- Dosage form
- Kit
- Labeler
- Krystal Biotech, Inc.NDC labeler code 82194
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125774
- Marketing start
- Listing expires
- Identifiers
- Product ID 82194-510_3ff07932-fac8-5b69-e063-6394a90a5cbeSPL ID 3ff07932-fac8-5b69-e063-6394a90a5cbeSPL set ID fe207c8c-04b4-4fdf-87cf-6dbc7eb6e9c2RxCUI 2637762, 2637767
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N482194051002followed by a unit qualifier and the quantityPackage 82194-0510-02. 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)
VYJUVEK is indicated for the treatment of wounds in adult and pediatric patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene. VYJUVEK is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy indicated for the treatment of wounds in adult and pediatric patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene. (1)
Excerpt only. Read the full label for complete information.
About NDC 82194-510
- What is NDC 82194-510?
- 82194-510 is the product NDC for Vyjuvek kit, listed with the FDA by Krystal Biotech, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vyjuvek.
- Who is the labeler?
- Krystal Biotech, Inc., NDC labeler code 82194. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vyjuvek?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.