Prescription drug · BLA
Ogivri (Trastuzumab) NDC 67457-991
Trastuzumab 150 mg/7.4mL · Injection, Powder, Lyophilized, For solution · Intravenous · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67457-991-15 | 6745709911567457099115 | 1 VIAL in 1 CARTON (67457-991-15) / 15 mL in 1 VIALMarketed 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
- Active ingredients
- Trastuzumab — 150 mg/7.4mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Mylan Institutional LLCNDC labeler code 67457
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761074
- Marketing start
- Marketing end
- Other FDA classes
- HER2/Neu/cerbB2 Antagonists (Mechanism)
- Identifiers
- Product ID 67457-991_b57e61b9-04b7-4d8b-b7c2-be56a060421bSPL ID b57e61b9-04b7-4d8b-b7c2-be56a060421b
- 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
N467457099115followed by a unit qualifier and the quantityPackage 67457-0991-15. 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 67457-991
- What is NDC 67457-991?
- 67457-991 is the product NDC for Ogivri (trastuzumab), Trastuzumab 150 mg/7.4mL injection, powder, lyophilized, for solution, 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).
- What is the active ingredient?
- 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?
- 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 | 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 | — | Kit | Mylan Institutional LLC | 67457-847 | 67457-0847-44 |
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-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 |