Prescription drug · BLA
Ogivri (Trastuzumab-dkst) NDC 83257-003
Trastuzumab 420 mg/20mL · Injection, Powder, Lyophilized, For solution · Intravenous · Biocon Biologics Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Ogivri
- Generic name (nonproprietary)
- trastuzumab-dkst
- Active ingredients
- Trastuzumab — 420 mg/20mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Biocon Biologics Inc.NDC labeler code 83257
- 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 83257-003_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.
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.
About NDC 83257-003
- What is NDC 83257-003?
- 83257-003 is the product NDC for Ogivri (trastuzumab-dkst), Trastuzumab 420 mg/20mL injection, powder, lyophilized, for solution, listed with the FDA by Biocon Biologics Inc..
- What drug is associated with this NDC?
- Ogivri (Trastuzumab-dkst).
- What is the active ingredient?
- Trastuzumab.
- Who is the labeler?
- Biocon Biologics Inc., NDC labeler code 83257. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ogivri?
- 4 other product NDCs are listed under this name. See all Ogivri NDCs.
- Is there a related HCPCS / J-code?
- Yes: J9355, Injection, trastuzumab, excludes biosimilar, 10 mg. See Billing references above.
Related NDCs: other Ogivri products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ogivritrastuzumab-dkst | Trastuzumab 150 mg/7.4mL | Injection, Powder, Lyophilized, For solutionIntravenous | Biocon Biologics Inc. | 83257-001 | 83257-0001-11 |
| Ogivritrastuzumab-dkst | — | Kit | Biocon Biologics Inc. | 83257-004 | 83257-0004-12 |
| Ogivritrastuzumab | — | Kit | Mylan Institutional LLC | 67457-847 | 67457-0847-44 |
| Ogivritrastuzumab | Trastuzumab 150 mg/7.4mL | Injection, Powder, Lyophilized, For solutionIntravenous | Mylan Institutional LLC | 67457-991 | 67457-0991-15 |
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 | — | Kit | Mylan Institutional LLC | 67457-847 |
| Ogivritrastuzumab | Trastuzumab 150 mg/7.4mL | Injection, Powder, Lyophilized, For solutionIntravenous | Mylan Institutional LLC | 67457-991 |
| 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 |