Ogivri (trastuzumab) NDC 67457-991 · J-Code J9355

NDC codes

FDA NDC Directory

Product NDC (as listed)67457-991Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67457-0991Add 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
67457-991-15	67457099115	1 VIAL in 1 CARTON (67457-991-15) / 15 mL in 1 VIALMarketed from Nov 29, 2019

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): Ogivri
Generic name (nonproprietary): trastuzumab
Active ingredients: Trastuzumab — 150 mg/7.4mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Mylan Institutional LLC
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761074
Marketing start: Nov 29, 2019
Marketing end: Feb 28, 2027
Other FDA classes: HER2/Neu/cerbB2 Antagonists (Mechanism)
Identifiers: Product ID 67457-991_b57e61b9-04b7-4d8b-b7c2-be56a060421bSPL ID b57e61b9-04b7-4d8b-b7c2-be56a060421b
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

N467457099115 followed by a unit qualifier and the quantity

Package 67457-0991-15. 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

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under BLA 761074

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

FDA NDC Directory listings under BLA 761074
Product	Strength	Form · route	Labeler	Product NDC
Ogivritrastuzumab-dkst	Trastuzumab 420 mg/20mL	Injection, Powder, Lyophilized, For solutionIntravenous	Biocon Biologics Inc.	83257-003
Ogivritrastuzumab-dkst	Trastuzumab 150 mg/7.4mL	Injection, Powder, Lyophilized, For solutionIntravenous	Biocon Biologics Inc.	83257-001
Ogivritrastuzumab-dkst	—	Kit	Biocon Biologics Inc.	83257-004
Ogivritrastuzumab	—	Kit	Mylan Institutional LLC	67457-847