NDC codes

FDA NDC Directory
Product NDC (as listed)82194-510Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82194-0510Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
82194-510-02821940510021 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

N482194051002 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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