HERCESSI
- Product NDC
- 69448-035
- 11-digit product format
- 694480035
- Labeler code
- 69448
- Product ID
- 69448-035_893932c5-c667-4ed0-a2bd-a62cc5800b14
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Trastuzumab-strf
- Dosage form
- KIT
- Labeler
- Accord BioPharma Inc.
- Application
- BLA761346
- Marketing category
- BLA
- Marketing start
- 2026-10-01
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- HERCESSI
- Listing expiration
- 2027-12-31
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bd11614e-4776-4a92-aaca-2bcbb5f710ed | Product name | 1 | 20210115 |
| b914e981-d6dc-4748-bd51-accd6b85b817 | Product name | 1 | 20190618 |
| 9397f6d4-17a1-42b4-beda-fa2c0ea40c8c | Product name | 1 | 20190610 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761346 | Hercessi | trastuzumab-strf | 351(k) Biosimilar | Rx | 2026-09-01 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2700724 | HERCESSI 150 MG Injection | PSN | 285d2142-5bfa-401c-9246-7de21c4451af | 4 |
| 2700731 | HERCESSI 420 MG in 20 ML Injectable Solution | PSN | 285d2142-5bfa-401c-9246-7de21c4451af | 4 |
| 2700718 | trastuzumab-strf 150 MG Injection | PSN | 285d2142-5bfa-401c-9246-7de21c4451af | 4 |
| 2700727 | trastuzumab-strf 420 MG in 20 ML Injectable Solution | PSN | 285d2142-5bfa-401c-9246-7de21c4451af | 4 |
| 2700724 | trastuzumab-strf 150 MG Injection [Hercessi] | SBD | 285d2142-5bfa-401c-9246-7de21c4451af | 4 |
| 2700731 | trastuzumab-strf 21 MG/ML Injectable Solution [Hercessi] | SBD | 285d2142-5bfa-401c-9246-7de21c4451af | 4 |
| 2700718 | trastuzumab-strf 150 MG Injection | SCD | 285d2142-5bfa-401c-9246-7de21c4451af | 4 |
| 2700727 | trastuzumab-strf 21 MG/ML Injectable Solution | SCD | 285d2142-5bfa-401c-9246-7de21c4451af | 4 |
| 2700724 | Hercessi 150 MG Injection | SY | 285d2142-5bfa-401c-9246-7de21c4451af | 4 |
| 2700731 | Hercessi 21 MG/ML Injectable Solution | SY | 285d2142-5bfa-401c-9246-7de21c4451af | 4 |
| 2700731 | Hercessi 420 MG per 20 ML Injectable Solution | SY | 285d2142-5bfa-401c-9246-7de21c4451af | 4 |
| 2700727 | trastuzumab-strf 420 MG per 20 ML Injectable Solution | SY | 285d2142-5bfa-401c-9246-7de21c4451af | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 69448-035-63 | 69448003563 | 1 KIT in 1 CARTON (69448-035-63) * 20 mL in 1 VIAL, MULTI-DOSE (69448-016-11) * 20 mL in 1 VIAL (69448-034-05) | 1 kit | 2026-10-01 | No | No | Current |