Prescription drug · BLA
Ontruzant (Trastuzumab) NDC 78206-147
Trastuzumab 150 mg/1 · Injection, Powder, Lyophilized, For solution · Intravenous · Organon LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78206-147-01 | 7820601470178206014701 | 1 VIAL, SINGLE-DOSE in 1 CARTON (78206-147-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (78206-147-99)Marketed from Jun 1, 2021 |
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)
- Ontruzant
- Generic name (nonproprietary)
- trastuzumab
- Active ingredients
- Trastuzumab — 150 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Organon LLCNDC labeler code 78206
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761100
- Marketing start
- Listing expires
- Other FDA classes
- HER2/Neu/cerbB2 Antagonists (Mechanism)
- Identifiers
- Product ID 78206-147_9b665849-a59e-4da6-ae51-36b3c885b85bSPL ID 9b665849-a59e-4da6-ae51-36b3c885b85bSPL set ID ce2a2492-85e3-4b0a-872a-047f44e4203dRxCUI 2289227, 2289232, 2289234, 2289237UNII P188ANX8CK
- Pharmacologic class
- HER2/neu Receptor Antagonist
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 codeMed-Code curated
J9355 — Injection, trastuzumab, excludes biosimilar, 10 mg
Billing unit: 10 mg. Units on the claim = dose given ÷ 10 mg.
Trastuzumab biosimilars and trastuzumab with hyaluronidase have their own HCPCS codes.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N478206014701followed by a unit qualifier and the quantityPackage 78206-0147-01. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Ontruzant is a HER2/neu receptor antagonist indicated in adults for: The treatment of HER2-overexpressing breast cancer. ( 1.1 , 1.2 ) The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. ( 1.3 ) Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product ( 1 , 2.2 ). 1.1 Adjuvant Breast Cancer Ontruzant is indicated in adults for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies (14.1) ] ) breast cancer as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel as…
Excerpt only. Read the full label for complete information.
About NDC 78206-147
- What is NDC 78206-147?
- 78206-147 is the product NDC for Ontruzant (trastuzumab), Trastuzumab 150 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by Organon LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ontruzant (Trastuzumab).
- What is the active ingredient?
- Trastuzumab.
- Who is the labeler?
- Organon LLC, NDC labeler code 78206. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ontruzant?
- 1 other product NDC are listed under this name. See all Ontruzant NDCs.
- Is there a related HCPCS / J-code?
- Yes: J9355, Injection, trastuzumab, excludes biosimilar, 10 mg. See Billing references above.
Related NDCs: other Ontruzant products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ontruzant | — | KitIntravenous | Organon LLC | 78206-148 | 78206-0148-01 |
Other NDCs under BLA 761100
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 |
|---|---|---|---|---|
| Ontruzant | — | KitIntravenous | Organon LLC | 78206-148 |