TIVDAK
- Product NDC
- 51144-003
- 11-digit product format
- 511440003
- Labeler code
- 51144
- Product ID
- 51144-003_2dbf1344-d74a-4d50-8070-d4e93801820f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tisotumab vedotin
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- SEAGEN INC.
- Application
- BLA761208
- Marketing category
- BLA
- Marketing start
- 2021-09-20
- Substance
- TISOTUMAB VEDOTIN
- Active strength
- 40 mg/4mL
- 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
- TIVDAK
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TISOTUMAB VEDOTIN | 40 mg/4mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51144-003-01 | TIVDAK | 1 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 1 | | 10 |
| 51144-003-01 | TIVDAK | 4 mL in 1 VIAL | INJECTION, POWDER, FOR SOLUTION | 4 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51144-003 | TIVDAK (TISOTUMAB VEDOTIN) INJECTION, POWDER, FOR SOLUTION [SEAGEN INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20241105_c9fe3f32-4219-466e-acb9-3f609b4f4df1.zip |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761208 | Tivdak | tisotumab vedotin-tftv | 351(a) | Rx | 2026-10-01 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51144-003-01 | 51144000301 | 1 VIAL in 1 CARTON (51144-003-01) / 4 mL in 1 VIAL | 1 vial | 2021-09-20 | 0000-00-00 | No | No | Current |