Trazimera (trastuzumab-qyyp) NDC 0069-0308

NDC codes

FDA NDC Directory

Product NDC (as listed)0069-0308Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00069-0308Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
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 Inc
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761081
Marketing start: Mar 10, 2021
Listing expires: Dec 31, 2027
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.

How CPT relates to drug billing

NDC on a medical claim

N400069030801 followed by a unit qualifier and the quantity

Package 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 Apr 10, 2026. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 761081

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 761081
Product	Strength	Form · route	Labeler	Product NDC
Trazimeratrastuzumab-qyyp	—	Kit	Pfizer Laboratories Div Pfizer Inc	0069-0305