Prescription drug · BLA
Tudriqev (Vusolimogene oderparepvec-wtpg) NDC 83616-106
Vusolimogene oderparepvec 1000000 [PFU]/mL · Injection, Suspension · Intratumor · Replimune, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83616-106-11 | 83616010611 | 1 VIAL, SINGLE-DOSE in 1 CARTON (83616-106-11) / 1 mL in 1 VIAL, SINGLE-DOSE (83616-106-01)Marketed from Sep 4, 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)
- Tudriqev
- Generic name (nonproprietary)
- vusolimogene oderparepvec-wtpg
- Active ingredients
- Vusolimogene oderparepvec — 1000000 [PFU]/mL
- Dosage form
- Injection, Suspension
- Route
- Intratumor
- Labeler
- Replimune, Inc.NDC labeler code 83616
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125827
- Marketing start
- Listing expires
- Identifiers
- Product ID 83616-106_1ddc4551-7fe8-4d58-952c-1d0dd1f6af67SPL ID 1ddc4551-7fe8-4d58-952c-1d0dd1f6af67
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
N483616010611followed by a unit qualifier and the quantityPackage 83616-0106-11. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 83616-106
- What is NDC 83616-106?
- 83616-106 is the product NDC for Tudriqev (vusolimogene oderparepvec-wtpg), Vusolimogene oderparepvec 1000000 [PFU]/mL injection, suspension, listed with the FDA by Replimune, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tudriqev (Vusolimogene oderparepvec-wtpg).
- What is the active ingredient?
- Vusolimogene oderparepvec.
- Who is the labeler?
- Replimune, Inc., NDC labeler code 83616. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tudriqev?
- 1 other product NDC are listed under this name. See all Tudriqev NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tudriqev products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tudriqevvusolimogene oderparepvec-wtpg | Vusolimogene oderparepvec 10000000 [PFU]/mL | Injection, SuspensionIntratumor | Replimune, Inc. | 83616-107 | 83616-0107-11 |
Other NDCs under BLA 125827
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 |
|---|---|---|---|---|
| Tudriqevvusolimogene oderparepvec-wtpg | Vusolimogene oderparepvec 10000000 [PFU]/mL | Injection, SuspensionIntratumor | Replimune, Inc. | 83616-107 |