KADCYLA
- Product NDC
- 50242-088
- 11-digit product format
- 502420088
- Labeler code
- 50242
- Product ID
- 50242-088_27ab596b-f625-4866-b65a-54508ffce760
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ADO-TRASTUZUMAB EMTANSINE
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Genentech, Inc.
- Application
- BLA125427
- Marketing category
- BLA
- Marketing start
- 2013-02-22
- Substance
- TRASTUZUMAB EMTANSINE
- Active strength
- 20 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- KADCYLA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRASTUZUMAB EMTANSINE | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SE2KH7T06F |
| Rxcui | 1658084, 1658087, 1658089, 1658091 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50242-088-01 | KADCYLA | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 35 |
| 50242-088-01 | KADCYLA | 5 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 5 | | 35 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ADO-TRASTUZUMAB EMTANSINE | ACTIVE INGREDIENT | SE2KH7T06F | KADCYLA (ADO-TRASTUZUMAB EMTANSINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.] | 5 | |
| ADO-TRASTUZUMAB EMTANSINE | ACTIVE MOIETY | SE2KH7T06F | KADCYLA (ADO-TRASTUZUMAB EMTANSINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.] | 5 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | KADCYLA (ADO-TRASTUZUMAB EMTANSINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.] | 5 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | KADCYLA (ADO-TRASTUZUMAB EMTANSINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.] | 5 | |
| SUCCINIC ACID | INACTIVE INGREDIENT | AB6MNQ6J6L | KADCYLA (ADO-TRASTUZUMAB EMTANSINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.] | 5 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | KADCYLA (ADO-TRASTUZUMAB EMTANSINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.] | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | KADCYLA (ADO-TRASTUZUMAB EMTANSINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50242-088 | KADCYLA (ADO-TRASTUZUMAB EMTANSINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.] | 30 | Current NDC, Legacy NDC, 2 package rows | 20250523_23f3c1f4-0fc8-4804-a9e3-04cf25dd302e.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 |
|---|
| 50242-088-01 | 50242008801 | 1 VIAL, SINGLE-USE in 1 CARTON (50242-088-01) / 5 mL in 1 VIAL, SINGLE-USE | 2013-02-22 | 0000-00-00 | No | No | Current |