Prescription drug · BLA
Ogivri (trastuzumab-dkst) NDC 83257-001
Trastuzumab 150 mg/7.4mL · Injection, Powder, Lyophilized, For solution · Intravenous · Biocon Biologics Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83257-001-11 | 83257000111 | 1 VIAL in 1 CARTON (83257-001-11) / 15 mL in 1 VIALMarketed 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
- Active ingredients
- Trastuzumab — 150 mg/7.4mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Biocon Biologics Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761074
- Marketing start
- Listing expires
- Other FDA classes
- HER2/Neu/cerbB2 Antagonists (Mechanism)
- Identifiers
- Product ID 83257-001_ed1bbb0a-ad1a-6cb6-e955-e9ae2ce9c40fSPL ID ed1bbb0a-ad1a-6cb6-e955-e9ae2ce9c40fSPL set ID b6465b44-a6dd-f99c-d009-6851cf05169cRxCUI 2179753, 2179758, 2179760, 2179763UNII 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
N483257000111followed by a unit qualifier and the quantityPackage 83257-0001-11. 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)
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.
Other NDCs under BLA 761074
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 | — | Kit | Biocon Biologics Inc. | 83257-004 |
| Ogivritrastuzumab | — | Kit | Mylan Institutional LLC | 67457-847 |
| Ogivritrastuzumab | Trastuzumab 150 mg/7.4mL | Injection, Powder, Lyophilized, For solutionIntravenous | Mylan Institutional LLC | 67457-991 |