Trazimera
- Product NDC
- 0069-0308
- 11-digit product format
- 000690308
- Labeler code
- 0069
- Product ID
- 0069-0308_6bb3d11b-6f9e-408c-a957-b7bacaf9e175
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- trastuzumab-qyyp
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Pfizer Laboratories Div Pfizer Inc
- Application
- BLA761081
- Marketing category
- BLA
- Marketing start
- 2021-03-10
- 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
- Trazimera
- 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 | 2280732, 2280737, 2472791, 2472794 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0069-0308-01 | Trazimera | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 9 |
| 0069-0308-01 | Trazimera | 7.15 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 7.15 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0069-0308 | TRAZIMERA (TRASTUZUMAB-QYYP) KIT TRAZIMERA (TRASTUZUMAB-QYYP) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20241222_b9c5e894-27d2-4245-a653-df986fed3c56.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0069-0308-01 | 00069030801 | 1 VIAL in 1 CARTON (0069-0308-01) / 7.15 mL in 1 VIAL | 1 vial | 2021-03-10 | 0000-00-00 | No | No | Current |