Kanjinti
- Product NDC
- 55513-141
- 11-digit product format
- 555130141
- Labeler code
- 55513
- Product ID
- 55513-141_94338615-f26e-4373-93ce-106894c98a87
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- trastuzumab-anns
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Amgen, Inc
- Application
- BLA761073
- Marketing category
- BLA
- Marketing start
- 2019-10-28
- Substance
- TRASTUZUMAB
- Active strength
- 150 mg/7.15mL
- Pharmacologic classes
- HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Kanjinti
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRASTUZUMAB | 150 mg/7.15mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | P188ANX8CK |
| Rxcui | 2174804, 2174809, 2257297, 2257300 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55513-141-01 | Kanjinti | 7.15 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 7.15 | | 22 |
| 55513-141-01 | Kanjinti | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 22 |
| 55513-141-21 | Kanjinti | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 22 |
| 55513-141-21 | Kanjinti | 7.15 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 7.15 | | 22 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55513-141 | KANJINTI (TRASTUZUMAB-ANNS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KANJINTI (TRASTUZUMAB-ANNS) KIT [AMGEN INC] | 19 | Current NDC, Legacy NDC, 4 package rows | 20250205_9a94f5b2-b84e-4987-8ea1-c4346db5a5fa.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 |
|---|
| 55513-141-01 | 55513014101 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55513-141-01) / 7.15 mL in 1 VIAL, SINGLE-DOSE | 2019-10-28 | 0000-00-00 | No | No | Current |
| 55513-141-21 | 55513014121 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55513-141-21) / 7.15 mL in 1 VIAL, SINGLE-DOSE | 2025-07-01 | | No | No | Historical |