Prescription drug · BLA
Ogivri (trastuzumab) NDC 67457-847
Kit · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67457-847-44 | 67457084744 | 1 KIT in 1 CARTON (67457-847-44) * 20 mL in 1 VIAL, MULTI-DOSE (67457-845-50) * 20 mL in 1 VIAL (67457-846-20)Marketed 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
- Dosage form
- Kit
- Labeler
- Mylan Institutional LLC
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761074
- Marketing start
- Marketing end
- Identifiers
- Product ID 67457-847_b57e61b9-04b7-4d8b-b7c2-be56a060421bSPL ID b57e61b9-04b7-4d8b-b7c2-be56a060421b
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
N467457084744followed by a unit qualifier and the quantityPackage 67457-0847-44. 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.
| 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 | Trastuzumab 150 mg/7.4mL | Injection, Powder, Lyophilized, For solutionIntravenous | Mylan Institutional LLC | 67457-991 |
- openFDA data updated
Med-Code stores this record for up to 24 hours before requesting it again.
Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.