Ogivri (trastuzumab-dkst) NDC 83257-004

NDC codes

FDA NDC Directory

Product NDC (as listed)83257-004Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83257-0004Add 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
83257-004-12	83257000412	1 KIT in 1 CARTON (83257-004-12) * 20 mL in 1 VIAL, MULTI-DOSE (83257-003-11) * 20 mL in 1 VIAL (83257-002-11)Marketed from Oct 1, 2023

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-dkst
Dosage form: Kit
Labeler: Biocon Biologics Inc.
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761074
Marketing start: Oct 1, 2023
Listing expires: Dec 31, 2027
Identifiers: Product ID 83257-004_ed1bbb0a-ad1a-6cb6-e955-e9ae2ce9c40fSPL ID ed1bbb0a-ad1a-6cb6-e955-e9ae2ce9c40fSPL set ID b6465b44-a6dd-f99c-d009-6851cf05169cRxCUI 2179753, 2179758, 2179760, 2179763UNII 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.

NDC on a medical claim

N483257000412 followed by a unit qualifier and the quantity

Package 83257-0004-12. 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 Jun 26, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Ogivri 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 Ogivri 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)