NDC codes

FDA NDC Directory
Product NDC (as listed)50242-132Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50242-0132Add 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 NDC11-digit (billing)PackageCopy
50242-132-01502420132011 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
Trastuzumab150 mg/7.4mL
Dosage form
Injection, Powder, Lyophilized, For solution
Route
Intravenous
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.

How CPT relates to drug billing

NDC on a medical claim

N450242013201 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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