Prescription drug · BLA
Kanjinti (trastuzumab-anns) NDC 55513-132
Trastuzumab 420 mg/20mL · Injection, Powder, Lyophilized, For solution · Intravenous · Amgen, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55513-132-01 | 55513013201 | 1 VIAL, MULTI-DOSE in 1 CARTON (55513-132-01) / 20 mL in 1 VIAL, MULTI-DOSEMarketed from Jun 11, 2019 | |
| 55513-132-21 | 55513013221 | 1 VIAL, MULTI-DOSE in 1 CARTON (55513-132-21) / 20 mL in 1 VIAL, MULTI-DOSEMarketed from Jul 1, 2025 |
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)
- Kanjinti
- Generic name (nonproprietary)
- trastuzumab-anns
- Active ingredients
- Trastuzumab — 420 mg/20mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Amgen, Inc
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761073
- Marketing start
- Listing expires
- Other FDA classes
- HER2/Neu/cerbB2 Antagonists (Mechanism)
- Identifiers
- Product ID 55513-132_0dfd83de-fa6d-43e4-8fb0-4a7c9b134ca7SPL ID 0dfd83de-fa6d-43e4-8fb0-4a7c9b134ca7SPL set ID 9a94f5b2-b84e-4987-8ea1-c4346db5a5faRxCUI 2174804, 2174809, 2257297, 2257300UNII 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
N455513013201followed by a unit qualifier and the quantityPackage 55513-0132-01. 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)
KANJINTI 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 KANJINTI 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 p…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 761073
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 |
|---|---|---|---|---|
| Kanjintitrastuzumab-anns | Trastuzumab 150 mg/7.15mL | Injection, Powder, Lyophilized, For solutionIntravenous | Amgen, Inc | 55513-141 |