IMDELLTRA (AMG757)
- Product NDC
- 55513-077
- Requested package NDC
- 55513-077-01
- 11-digit product format
- 555130077
- Labeler code
- 55513
- Product ID
- 55513-077_5e18b17d-1665-4984-a11b-0b55a82aa9fd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tarlatamab-dlle
- Dosage form
- KIT
- Labeler
- Amgen, Inc
- Application
- BLA761344
- Marketing category
- BLA
- Marketing start
- 2024-05-16
- 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
- IMDELLTRA (AMG757)
- Listing expiration
- 2027-12-31
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55513-069-01 | IMDELLTRA (AMG757) | 10 mg in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 mg | 2.4 mg in 1mg | 5 |
| 55513-077-01 | IMDELLTRA (AMG757) | 1 in 1 PACKAGE | KIT | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55513-077 | IMDELLTRA (AMG757) (TARLATAMAB-DLLE) KIT [AMGEN INC] | 3 | Current NDC, 2 package rows | 20240718_1e7b6163-5d83-42ea-82c9-cf7620cdc782.zip |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761344 | Imdelltra | tarlatamab-dlle | 351(a) | Rx | 2026-09-01 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 55513-077-01 | 55513007701 | 1 KIT in 1 PACKAGE (55513-077-01) * 10 mg in 1 VIAL (55513-069-01) * 7 mL in 1 VIAL (55513-068-01) | 1 kit | 2024-06-12 | No | No | Current |