Enhertu
- Product NDC
- 65597-406
- 11-digit product format
- 655970406
- Labeler code
- 65597
- Product ID
- 65597-406_50272b50-1dd2-49a0-a74e-e6e182decb79
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fam-trastuzumab deruxtecan-nxki
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Daiichi Sankyo Inc.
- Application
- BLA761139
- Marketing category
- BLA
- Marketing start
- 2019-12-20
- Substance
- TRASTUZUMAB DERUXTECAN
- Active strength
- 100 mg/5mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Enhertu
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRASTUZUMAB DERUXTECAN | 100 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5384HK7574 |
| Rxcui | 2267576, 2267581 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65597-406-01 | Enhertu | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 28 |
| 65597-406-01 | Enhertu | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 5 | | 28 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65597-406 | ENHERTU (FAM-TRASTUZUMAB DERUXTECAN-NXKI) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [DAIICHI SANKYO INC.] | 21 | Current NDC, Legacy NDC, 2 package rows | 20250522_7e67e73e-ddf4-4e4d-8b50-09d7514910b6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65597-406-01 | 65597040601 | 1 VIAL, SINGLE-DOSE in 1 CARTON (65597-406-01) / 5 mL in 1 VIAL, SINGLE-DOSE | 2019-12-20 | 0000-00-00 | No | No | Current |