Prescription drug · BLA
Avlayah (Tividenofusp alfa-eknm) NDC 84976-001
Tividenofusp alfa 150 mg/5mL · Injection, Powder, Lyophilized, For solution · Intravenous · Denali Therapeutics Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84976-001-01 | 84976000101 | 1 VIAL in 1 CARTON (84976-001-01) / 5 mL in 1 VIALMarketed from Apr 6, 2026 |
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)
- Avlayah
- Generic name (nonproprietary)
- tividenofusp alfa-eknm
- Active ingredients
- Tividenofusp alfa — 150 mg/5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Denali Therapeutics Inc.NDC labeler code 84976
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761485
- Marketing start
- Listing expires
- Identifiers
- Product ID 84976-001_352edb2c-39aa-4955-b456-f5c731b746d0SPL ID 352edb2c-39aa-4955-b456-f5c731b746d0SPL set ID 014d92c1-b643-4680-8ca6-f0b3307da915RxCUI 2740019, 2740025UNII QLD7UJN8CF
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
N484976000101followed by a unit qualifier and the quantityPackage 84976-0001-01. 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)
AVLAYAH is indicated for the treatment of neurologic manifestations of Hunter syndrome (Mucopolysaccharidosis type II, MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment. This indication is approved under accelerated approval based on the reduction of cerebrospinal fluid heparan sulfate [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Limitations of Use AVLAYAH is not recommended for use in combination with other enzyme replacement therapies for the treatment of Hunter syndrome. AVLAYAH …
Excerpt only. Read the full label for complete information.
About NDC 84976-001
- What is NDC 84976-001?
- 84976-001 is the product NDC for Avlayah (tividenofusp alfa-eknm), Tividenofusp alfa 150 mg/5mL injection, powder, lyophilized, for solution, listed with the FDA by Denali Therapeutics Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Avlayah (Tividenofusp alfa-eknm).
- What is the active ingredient?
- Tividenofusp alfa.
- Who is the labeler?
- Denali Therapeutics Inc., NDC labeler code 84976. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Avlayah?
- 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.