Prescription drug · BLA
Margenza (margetuximab-cmkb) NDC 74527-022
Margetuximab 25 mg/mL · Injection, Solution, Concentrate · Intravenous · MacroGenics, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 74527-022-02 | 74527002202 | 1 VIAL, SINGLE-DOSE in 1 CARTON (74527-022-02) / 10 mL in 1 VIAL, SINGLE-DOSE (74527-022-01)Marketed from Jan 15, 2021 | |
| 74527-022-03 | 74527002203 | 4 VIAL, SINGLE-DOSE in 1 CARTON (74527-022-03) / 10 mL in 1 VIAL, SINGLE-DOSE (74527-022-01)Marketed from Jan 15, 2021 |
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)
- Margenza
- Generic name (nonproprietary)
- margetuximab-cmkb
- Active ingredients
- Margetuximab — 25 mg/mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- MacroGenics, Inc
- 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 74527-022_97ee3be5-cd7f-45d4-85c7-b48ad596e837SPL ID 97ee3be5-cd7f-45d4-85c7-b48ad596e837SPL set ID e97a5872-eabf-463b-8f4c-5b5aed9c7bf0RxCUI 2474028, 2474033UNII K911R84KEW
- 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.
- NDC on a medical claim
N474527002202followed by a unit qualifier and the quantityPackage 74527-0022-02. 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)
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.
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 | TerSera Therapeutics LLC | 70720-022 |