Cellular therapy · BLA
Skysona (Elivaldogene autotemcel) NDC 73554-2111
Elivaldogene autotemcel 30000000 1/1 · Suspension · Intravenous · Genetix Biotherapeutics Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73554-2111-1 | 73554211101 | 1 SUSPENSION in 1 BAG (73554-2111-1)Marketed from Sep 16, 2022 |
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)
- Skysona
- Generic name (nonproprietary)
- elivaldogene autotemcel
- Active ingredients
- Elivaldogene autotemcel — 30000000 1/1
- Dosage form
- Suspension
- Route
- Intravenous
- Labeler
- Genetix Biotherapeutics Inc.NDC labeler code 73554
- Product type
- Cellular therapy
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125755
- Marketing start
- Listing expires
- Identifiers
- Product ID 73554-2111_ce3d399f-9c4f-41c1-a4a3-09bafcdbceb4SPL ID ce3d399f-9c4f-41c1-a4a3-09bafcdbceb4SPL set ID f189502b-dc44-4289-99a6-cfba36918329RxCUI 2612552, 2612558UNII KUM75TD6SGUPC 0373554211117
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
N473554211101followed by a unit qualifier and the quantityPackage 73554-2111-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
SKYSONA is indicated to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD) without an available human leukocyte antigen (HLA)-matched donor for allogeneic hematopoietic stem cell transplant. Early, active cerebral adrenoleukodystrophy refers to asymptomatic or mildly symptomatic (neurologic function score, NFS ≤ 1) boys who have gadolinium enhancement on brain magnetic resonance imaging (MRI) and Loes scores of 0.5-9. This indication is approved under accelerated approval based on 24-month Major Functional Disability (MFD)-free survival [see Clinical Studies (14) ] . Continued approval for this indication may be co…
Excerpt only. Read the full label for complete information.
About NDC 73554-2111
- What is NDC 73554-2111?
- 73554-2111 is the product NDC for Skysona (elivaldogene autotemcel), Elivaldogene autotemcel 30000000 1/1 suspension, listed with the FDA by Genetix Biotherapeutics Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Skysona (Elivaldogene autotemcel).
- What is the active ingredient?
- Elivaldogene autotemcel.
- Who is the labeler?
- Genetix Biotherapeutics Inc., NDC labeler code 73554. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Skysona?
- 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.