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 | 6745708474467457084744 | 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 LLCNDC labeler code 67457
- 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.
About NDC 67457-847
- What is NDC 67457-847?
- 67457-847 is the product NDC for Ogivri (trastuzumab) kit, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ogivri (Trastuzumab).
- Who is the labeler?
- Mylan Institutional LLC, NDC labeler code 67457. 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-dkst | — | Kit | Biocon Biologics Inc. | 83257-004 | 83257-0004-12 |
| 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 | 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 |
| Ogivritrastuzumab-dkst | — | Kit | Biocon Biologics Inc. | 83257-004 |