EMRELIS
- Product NDC
- 0074-1044
- 11-digit product format
- 000741044
- Labeler code
- 0074
- Product ID
- 0074-1044_998985bb-7cd1-4e80-bd08-8fc7c503f982
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Telisotuzumab Vedotin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- AbbVie Inc.
- Application
- BLA761384
- Marketing category
- BLA
- Marketing start
- 2025-05-14
- Substance
- TELISOTUZUMAB VEDOTIN
- Active strength
- 20 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- EMRELIS
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TELISOTUZUMAB VEDOTIN | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 976X9VXC3Z |
| Rxcui | 2714245, 2714251, 2714253, 2714255 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0074-1044-01 | EMRELIS | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 3 |
| 0074-1044-01 | EMRELIS | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0074-1044 | TELISOTUZUMAB VEDOTIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ABBVIE INC.] | 2 | Current NDC, 2 package rows | 20250516_bc04f980-3957-4e35-ab81-8ec2ffe87215.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0074-1044-01 | 00074104401 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0074-1044-01) / 1 mL in 1 VIAL, SINGLE-DOSE | 2025-05-14 | No | No | Current |