Prescription drug · BLA
Trazimera (Trastuzumab-qyyp) NDC 0069-0308
Trastuzumab 150 mg/7.15mL · Injection, Powder, Lyophilized, For solution · Intravenous · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0069-0308-01 | 00069030801 | 1 VIAL in 1 CARTON (0069-0308-01) / 7.15 mL in 1 VIALMarketed from Mar 10, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Trazimera
- Generic name (nonproprietary)
- trastuzumab-qyyp
- Active ingredients
- Trastuzumab — 150 mg/7.15mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Pfizer Laboratories Div Pfizer IncNDC labeler code 0069
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761081
- Marketing start
- Listing expires
- Other FDA classes
- HER2/Neu/cerbB2 Antagonists (Mechanism)
- Identifiers
- Product ID 0069-0308_6bb3d11b-6f9e-408c-a957-b7bacaf9e175SPL ID 6bb3d11b-6f9e-408c-a957-b7bacaf9e175SPL set ID b9c5e894-27d2-4245-a653-df986fed3c56RxCUI 2280732, 2280737, 2472791, 2472794UNII 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
N400069030801followed by a unit qualifier and the quantityPackage 00069-0308-01. 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)
TRAZIMERA 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 TRAZIMERA 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 doceta…
Excerpt only. Read the full label for complete information.
About NDC 0069-0308
- What is NDC 0069-0308?
- 0069-0308 is the product NDC for Trazimera (trastuzumab-qyyp), Trastuzumab 150 mg/7.15mL injection, powder, lyophilized, for solution, listed with the FDA by Pfizer Laboratories Div Pfizer Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Trazimera (Trastuzumab-qyyp).
- What is the active ingredient?
- Trastuzumab.
- Who is the labeler?
- Pfizer Laboratories Div Pfizer Inc, NDC labeler code 0069. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Trazimera?
- 1 other product NDC are listed under this name. See all Trazimera NDCs.
- Is there a related HCPCS / J-code?
- Yes: J9355, Injection, trastuzumab, excludes biosimilar, 10 mg. See Billing references above.
Related NDCs: other Trazimera products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Trazimeratrastuzumab-qyyp | — | Kit | Pfizer Laboratories Div Pfizer Inc | 0069-0305 | 00069-0305-01 |
Other NDCs under BLA 761081
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 |
|---|---|---|---|---|
| Trazimeratrastuzumab-qyyp | — | Kit | Pfizer Laboratories Div Pfizer Inc | 0069-0305 |