Prescription drug · BLA
Kebilidi (Eladocagene exuparvovec-tneq) NDC 52856-601
Eladocagene exuparvovec 560000000000 {GC}/mL · Suspension · Intracerebral · PTC Therapeutics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52856-601-01 | 52856060101 | 1 VIAL, GLASS in 1 CARTON (52856-601-01) / .5 mL in 1 VIAL, GLASS (52856-601-11)Marketed from Nov 13, 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)
- Kebilidi
- Generic name (nonproprietary)
- eladocagene exuparvovec-tneq
- Active ingredients
- Eladocagene exuparvovec — 560000000000 {GC}/mL
- Dosage form
- Suspension
- Route
- Intracerebral
- Labeler
- PTC Therapeutics, Inc.NDC labeler code 52856
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125722
- Marketing start
- Listing expires
- Identifiers
- Product ID 52856-601_9a102e64-6ff8-41bd-8195-932aaf85b31cSPL ID 9a102e64-6ff8-41bd-8195-932aaf85b31cSPL set ID 9d6a6401-c6b5-4f29-af11-67707d249482RxCUI 2698771, 2698778UNII S51J6N56M7UPC 0352856601017
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
N452856060101followed by a unit qualifier and the quantityPackage 52856-0601-01. 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)
KEBILIDI (eladocagene exuparvovec-tneq) is an adeno-associated virus (AAV) vector-based gene therapy indicated for the treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency. This indication is approved under accelerated approval based on the change from baseline in gross motor milestone achievement at 48 weeks post treatment [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial. KEBILIDI is an adeno-associated virus (AAV) vector-based gene therapy indicated for the treatment of adult and pediatric patients with aromatic L ami…
Excerpt only. Read the full label for complete information.
About NDC 52856-601
- What is NDC 52856-601?
- 52856-601 is the product NDC for Kebilidi (eladocagene exuparvovec-tneq), Eladocagene exuparvovec 560000000000 {GC}/mL suspension, listed with the FDA by PTC Therapeutics, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Kebilidi (Eladocagene exuparvovec-tneq).
- What is the active ingredient?
- Eladocagene exuparvovec.
- Who is the labeler?
- PTC Therapeutics, Inc., NDC labeler code 52856. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Kebilidi?
- 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.