Prescription drug · BLA
Margenza (Margetuximab-cmkb) NDC 70720-022
Margetuximab 25 mg/mL · Injection, Solution, Concentrate · Intravenous · TerSera Therapeutics LLC
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Margenza
- Generic name (nonproprietary)
- margetuximab-cmkb
- Active ingredients
- Margetuximab — 25 mg/mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- TerSera Therapeutics LLCNDC labeler code 70720
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761150
- Marketing start
- Listing expires
- Other FDA classes
- HER2/Neu/cerbB2 Antagonists (Mechanism)
- Identifiers
- Product ID 70720-022_6a6d50c7-06ea-479c-83cc-f197a9e428c9SPL ID 6a6d50c7-06ea-479c-83cc-f197a9e428c9SPL set ID 6a6d50c7-06ea-479c-83cc-f197a9e428c9RxCUI 2474028, 2474033UNII K911R84KEWUPC 0374527022020
- 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 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.
- 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)
MARGENZA is indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease [see Dosage and Administration (2.1) and Clinical Studies (14.1) ]. MARGENZA is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. ( 1 , 2.1 , 14.1 )
Excerpt only. Read the full label for complete information.
About NDC 70720-022
- What is NDC 70720-022?
- 70720-022 is the product NDC for Margenza (margetuximab-cmkb), Margetuximab 25 mg/mL injection, solution, concentrate, listed with the FDA by TerSera Therapeutics LLC.
- What drug is associated with this NDC?
- Margenza (Margetuximab-cmkb).
- What is the active ingredient?
- Margetuximab.
- Who is the labeler?
- TerSera Therapeutics LLC, NDC labeler code 70720. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Margenza?
- 1 other product NDC are listed under this name. See all Margenza NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Margenza products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Margenzamargetuximab-cmkb | Margetuximab 25 mg/mL | Injection, Solution, ConcentrateIntravenous | MacroGenics, Inc | 74527-022 | 74527-0022-0274527-0022-03 |
Other NDCs under BLA 761150
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 |
|---|---|---|---|---|
| Margenzamargetuximab-cmkb | Margetuximab 25 mg/mL | Injection, Solution, ConcentrateIntravenous | MacroGenics, Inc | 74527-022 |