HERCESSI
- Product NDC
- 69448-016
- 11-digit product format
- 694480016
- Labeler code
- 69448
- Product ID
- 69448-016_472e3da5-bba8-1d0e-e063-6394a90af880
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Trastuzumab-strf
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Accord BioPharma Inc.
- Application
- BLA761346
- Marketing category
- BLA
- Marketing start
- 2025-01-01
- Substance
- TRASTUZUMAB-STRF
- Active strength
- 420 mg/20mL
- 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
- HERCESSI
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TRASTUZUMAB-STRF | 420 mg/20mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69448-016-11 | HERCESSI | 20 mL in 1 VIAL, MULTI-DOSE | INJECTION, POWDER, LYOPHILIZED, | 20 | | 4 |
| 69448-016-11 | HERCESSI | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69448-016 | HERCESSI (TRASTUZUMAB-STRF) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD BIOPHARMA INC.] | 4 | Current NDC, 2 package rows | 20250323_285d2142-5bfa-401c-9246-7de21c4451af.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69448-016-11 | 69448001611 | 1 VIAL, MULTI-DOSE in 1 CARTON (69448-016-11) / 20 mL in 1 VIAL, MULTI-DOSE | 2025-01-01 | No | No | Current |