HERZUMA
- Product NDC
- 63459-303
- 11-digit product format
- 634590303
- Labeler code
- 63459
- Product ID
- 63459-303_49f6182a-5e0f-45ea-8a0f-b774ef28a98f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRASTUZUMAB
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Cephalon, Inc.
- Application
- BLA761091
- Marketing category
- BLA
- Marketing start
- 2020-03-16
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- HERZUMA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRASTUZUMAB | 150 mg/7.15mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | P188ANX8CK |
| Rxcui | 2107053, 2107058, 2169359, 2169362 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63459-303-43 | HERZUMA | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 14 |
| 63459-303-43 | HERZUMA | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 20 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63459-303 | HERZUMA (TRASTUZUMAB) KIT HERZUMA (TRASTUZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CEPHALON, INC.] | 13 | Current NDC, Legacy NDC, 2 package rows | 20250419_ae71c003-883a-4cd8-ad50-e8cc9a54e971.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 |
|---|
| 63459-303-43 | 63459030343 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63459-303-43) / 20 mL in 1 VIAL, SINGLE-DOSE | 2020-03-16 | 0000-00-00 | No | No | Current |