Prescription drug · BLA
Waskyra (Etuvetidigene autotemcel) NDC 87668-0100
Etuvetidigene autotemcel 1000000 U/mL · Injection · Intravenous · Orphan Therapies LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 87668-0100-1 | 87668010001 | 20 mL in 1 BAG (87668-0100-1)Marketed from Jul 23, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Waskyra
- Generic name (nonproprietary)
- etuvetidigene autotemcel
- Active ingredients
- Etuvetidigene autotemcel — 1000000 U/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Orphan Therapies LLCNDC labeler code 87668
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125846
- Marketing start
- Listing expires
- Identifiers
- Product ID 87668-0100_63947490-d64f-4313-8dfc-9f2ffc40c991SPL ID 63947490-d64f-4313-8dfc-9f2ffc40c991SPL set ID 106880df-7a30-4a0f-9e16-9f20fcc7d138RxCUI 2747661, 2747667UNII SMN5E7TJ9C
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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N487668010001followed by a unit qualifier and the quantityPackage 87668-0100-01. 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)
WASKYRA ® is indicated for the treatment of pediatric patients aged 6 months and older and adults with Wiskott-Aldrich Syndrome (WAS) who have a mutation in the WAS gene and for whom hematopoietic stem cell transplantation (HSCT) is appropriate and no suitable human leukocyte antigen (HLA)-matched related stem cell donor is available. WASKYRA ® is an autologous hematopoietic stem cell-based gene therapy indicated for the treatment of pediatric patients aged 6 months and older and adults with Wiskott-Aldrich Syndrome (WAS) who have a mutation in the WAS gene for whom hematopoietic stem cell transplantation (HSCT) is appropriate and no suitable human leukocyte antigen (HLA)-matched related hem…
Excerpt only. Read the full label for complete information.
About NDC 87668-0100
- What is NDC 87668-0100?
- 87668-0100 is the product NDC for Waskyra (etuvetidigene autotemcel), Etuvetidigene autotemcel 1000000 U/mL injection, listed with the FDA by Orphan Therapies LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Waskyra (Etuvetidigene autotemcel).
- What is the active ingredient?
- Etuvetidigene autotemcel.
- Who is the labeler?
- Orphan Therapies LLC, NDC labeler code 87668. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Waskyra?
- 1 other product NDC are listed under this name. See all Waskyra NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Waskyra products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Waskyraetuvetidigene autotemcel | Etuvetidigene autotemcel 1000000 U/mL | InjectionIntravenous | Fondazione Telethon ETS | 87233-0100 | 87233-0100-01 |
Other NDCs under BLA 125846
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 |
|---|---|---|---|---|
| Waskyraetuvetidigene autotemcel | Etuvetidigene autotemcel 1000000 U/mL | InjectionIntravenous | Fondazione Telethon ETS | 87233-0100 |