Tudriqev
- Product NDC
- 83616-106
- Requested package NDC
- 83616-106-11
- 11-digit product format
- 836160106
- Labeler code
- 83616
- Product ID
- 83616-106_1ddc4551-7fe8-4d58-952c-1d0dd1f6af67
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- vusolimogene oderparepvec-wtpg
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRATUMOR
- Labeler
- Replimune, Inc.
- Application
- BLA125827
- Marketing category
- BLA
- Marketing start
- 2026-09-04
- Substance
- VUSOLIMOGENE ODERPAREPVEC
- Active strength
- 1000000 [PFU]/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tudriqev
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VUSOLIMOGENE ODERPAREPVEC | 1000000 [PFU]/mL |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125827 | TUDRIQEV | vusolimogene oderparepvec-wtpg | 351(a) | Rx | 2026-09-01 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 83616-106-11 | 83616010611 | 1 VIAL, SINGLE-DOSE in 1 CARTON (83616-106-11) / 1 mL in 1 VIAL, SINGLE-DOSE (83616-106-01) | 2026-09-04 | No | No | Current |