What is NDC 78206-148?

78206-148 is the product NDC for Ontruzant kit, listed with the FDA by Organon LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Organon LLC, NDC labeler code 78206. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Ontruzant?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ontruzant NDC 78206-148 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)78206-148Labeler and product segments. Claims need a package NDC.

Product NDC at billing width78206-0148Add 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
78206-148-01	7820601480178206014801	1 KIT in 1 CARTON (78206-148-01) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE (78206-191-99) * 1 INJECTION, SOLUTION in 1 VIAL (78206-149-89)Marketed from Jun 1, 2021

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): Ontruzant
Generic name (nonproprietary): ontruzant
Dosage form: Kit
Route: Intravenous
Labeler: Organon LLCNDC labeler code 78206
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761100
Marketing start: Jun 1, 2021
Listing expires: Dec 31, 2027
Identifiers: Product ID 78206-148_9b665849-a59e-4da6-ae51-36b3c885b85bSPL ID 9b665849-a59e-4da6-ae51-36b3c885b85bSPL set ID ce2a2492-85e3-4b0a-872a-047f44e4203dRxCUI 2289227, 2289232, 2289234, 2289237UNII P188ANX8CK

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 codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

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

N478206014801 followed by a unit qualifier and the quantity

Package 78206-0148-01. 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 20, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Ontruzant 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 Ontruzant 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 78206-148

What is NDC 78206-148?: 78206-148 is the product NDC for Ontruzant kit, listed with the FDA by Organon LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ontruzant.
Who is the labeler?: Organon LLC, NDC labeler code 78206. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ontruzant?: 1 other product NDC are listed under this name. See all Ontruzant NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Ontruzant NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ontruzanttrastuzumab	Trastuzumab 150 mg/1	Injection, Powder, Lyophilized, For solutionIntravenous	Organon LLC	78206-147	78206-0147-01

Other NDCs under BLA 761100

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

FDA NDC Directory listings under BLA 761100
Product	Strength	Form · route	Labeler	Product NDC
Ontruzanttrastuzumab	Trastuzumab 150 mg/1	Injection, Powder, Lyophilized, For solutionIntravenous	Organon LLC	78206-147