PERJETA
- Product NDC
- 50242-145
- 11-digit product format
- 502420145
- Labeler code
- 50242
- Product ID
- 50242-145_dfebfe9c-a0c5-41d8-bf11-ed643627e264
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pertuzumab
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Genentech, Inc.
- Application
- BLA125409
- Marketing category
- BLA
- Marketing start
- 2012-06-08
- Substance
- PERTUZUMAB
- Active strength
- 30 mg/mL
- 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
- PERJETA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PERTUZUMAB | 30 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | K16AIQ8CTM |
| Rxcui | 1298948, 1298953 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50242-145-01 | PERJETA | 14 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION, CONCENTRATE | 14 | | 27 |
| 50242-145-01 | PERJETA | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 27 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Pertuzumab | ACTIVE INGREDIENT | K16AIQ8CTM | PERJETA (PERTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENENTECH, INC.] | 5 | |
| Pertuzumab | ACTIVE MOIETY | K16AIQ8CTM | PERJETA (PERTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENENTECH, INC.] | 5 | |
| acetic acid | INACTIVE INGREDIENT | Q40Q9N063P | PERJETA (PERTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENENTECH, INC.] | 5 | |
| histidine | INACTIVE INGREDIENT | 4QD397987E | PERJETA (PERTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENENTECH, INC.] | 5 | |
| polysorbate 20 | INACTIVE INGREDIENT | 7T1F30V5YH | PERJETA (PERTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENENTECH, INC.] | 5 | |
| sucrose | INACTIVE INGREDIENT | C151H8M554 | PERJETA (PERTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENENTECH, INC.] | 5 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | PERJETA (PERTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENENTECH, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50242-145 | PERJETA (PERTUZUMAB) INJECTION, SOLUTION, CONCENTRATE [GENENTECH, INC.] | 22 | Current NDC, Legacy NDC, 2 package rows | 20250509_17f85d17-ab71-4f5b-9fe3-0b8c822f69ff.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 |
|---|
| 50242-145-01 | 50242014501 | 1 VIAL, SINGLE-USE in 1 CARTON (50242-145-01) / 14 mL in 1 VIAL, SINGLE-USE | 2012-06-08 | 0000-00-00 | No | No | Current |