Prescription drug · BLA
Hercessi (Trastuzumab-strf) NDC 69448-035
Kit · Accord BioPharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69448-035-63 | 6944800356369448003563 | 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)Marketed from Oct 1, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Hercessi
- Generic name (nonproprietary)
- trastuzumab-strf
- Dosage form
- Kit
- Labeler
- Accord BioPharma Inc.NDC labeler code 69448
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761346
- Marketing start
- Listing expires
- Identifiers
- Product ID 69448-035_893932c5-c667-4ed0-a2bd-a62cc5800b14SPL ID 893932c5-c667-4ed0-a2bd-a62cc5800b14
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N469448003563followed by a unit qualifier and the quantityPackage 69448-0035-63. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
The FDA listing for this product does not reference a label (SPL) set.
About NDC 69448-035
- What is NDC 69448-035?
- 69448-035 is the product NDC for Hercessi (trastuzumab-strf) kit, listed with the FDA by Accord BioPharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hercessi (Trastuzumab-strf).
- Who is the labeler?
- Accord BioPharma Inc., NDC labeler code 69448. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hercessi?
- 2 other product NDCs are listed under this name. See all Hercessi NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hercessi products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hercessitrastuzumab-strf | Trastuzumab-strf 150 mg/7.4mL | Injection, Powder, Lyophilized, For solutionIntravenous | Accord BioPharma Inc. | 69448-015 | 69448-0015-05 |
| Hercessitrastuzumab-strf | Trastuzumab-strf 420 mg/20mL | Injection, Powder, Lyophilized, For solutionIntravenous | Accord BioPharma Inc. | 69448-016 | 69448-0016-11 |
Other NDCs under BLA 761346
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Hercessitrastuzumab-strf | Trastuzumab-strf 150 mg/7.4mL | Injection, Powder, Lyophilized, For solutionIntravenous | Accord BioPharma Inc. | 69448-015 |
| Hercessitrastuzumab-strf | Trastuzumab-strf 420 mg/20mL | Injection, Powder, Lyophilized, For solutionIntravenous | Accord BioPharma Inc. | 69448-016 |