Prescription drug · BLA
Ogivri (Trastuzumab-dkst) NDC 83257-004
Kit · Biocon Biologics Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83257-004-12 | 8325700041283257000412 | 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.NDC labeler code 83257
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761074
- Marketing start
- Listing expires
- 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
N483257000412followed by a unit qualifier and the quantityPackage 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 . 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 83257-004
- What is NDC 83257-004?
- 83257-004 is the product NDC for Ogivri (trastuzumab-dkst) kit, listed with the FDA by Biocon Biologics Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ogivri (Trastuzumab-dkst).
- 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?
- Not in Med-Code's curated HCPCS directory. 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 | Trastuzumab 420 mg/20mL | Injection, Powder, Lyophilized, For solutionIntravenous | Biocon Biologics Inc. | 83257-003 | — |
| 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 | Trastuzumab 420 mg/20mL | Injection, Powder, Lyophilized, For solutionIntravenous | Biocon Biologics Inc. | 83257-003 |