Prescription drug · BLA
Herceptin (trastuzumab) NDC 50242-132
Trastuzumab 150 mg/7.4mL · Injection, Powder, Lyophilized, For solution · Intravenous · Genentech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50242-132-01 | 50242013201 | 1 VIAL, SINGLE-DOSE in 1 CARTON (50242-132-01) / 15 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 10, 2017 |
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)
- Herceptin
- Generic name (nonproprietary)
- trastuzumab
- Active ingredients
- Trastuzumab — 150 mg/7.4mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Genentech, Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103792
- Marketing start
- Listing expires
- Other FDA classes
- HER2/Neu/cerbB2 Antagonists (Mechanism)
- Identifiers
- Product ID 50242-132_7517f775-6a10-4ddd-8dfb-6704ece413d0SPL ID 7517f775-6a10-4ddd-8dfb-6704ece413d0SPL set ID 492dbdb2-077e-4064-bff3-372d6af0a7a2RxCUI 1922509, 1922512UNII 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
N450242013201followed by a unit qualifier and the quantityPackage 50242-0132-01. 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)
Herceptin 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-authorized companion diagnostic for Herceptin ( 1 , 2.2 ). 1.1 Adjuvant Breast Cancer Herceptin 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 part of a…
Excerpt only. Read the full label for complete information.
- Source
- FDA NDC Directory via openFDA; FDA SPL via openFDA and DailyMed; Med-Code HCPCS directory (curated)
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.