margenza

Generic: margetuximab-cmkb

Labeler: tersera therapeutics llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name margenza
Generic Name margetuximab-cmkb
Labeler tersera therapeutics llc
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

margetuximab 25 mg/mL

Manufacturer
TerSera Therapeutics LLC

Identifiers & Regulatory

Product NDC 70720-022
Product ID 70720-022_6a6d50c7-06ea-479c-83cc-f197a9e428c9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761150
Listing Expiration 2026-12-31
Marketing Start 2021-01-15

Pharmacologic Class

Established (EPC)
her2/neu receptor antagonist [epc]
Mechanism of Action
her2/neu/cerbb2 antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70720022
Hyphenated Format 70720-022

Supplemental Identifiers

RxCUI
2474028 2474033
UPC
0374527022020
UNII
K911R84KEW
NUI
N0000175661 N0000020008

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name margenza (source: ndc)
Generic Name margetuximab-cmkb (source: ndc)
Application Number BLA761150 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied MARGENZA (margetuximab-cmkb) injection is a clear to slightly opalescent, colorless to pale yellow or pale brown solution in a single-dose vial supplied as: Carton Contents NDC One 250 mg/10 mL (25 mg/mL) single-dose vial NDC 70720-022-02 Four 250 mg/10 mL (25 mg/mL) single-dose vials NDC 70720-022-03 16.2 Storage Store vials refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light until time of use. Do not freeze. Do not shake.
  • PRINCIPAL DISPLAY PANEL - 250 mg/10 mL Vial Carton Rx only NDC 70720-022-02 Margenza ® (margetuximab-cmkb) Injection 250 mg/10 mL (25 mg/mL) For Intravenous Infusion After Dilution Single-Dose Vial Discard Unused Portion 1 Vial TerSera therapeutics PRINCIPAL DISPLAY PANEL - 250 mg/10 mL Vial Carton
source: label

Packages (0)

No package records.

Ingredients (1)

margetuximab (25 mg/mL)

Linked Drug Pages (1)

MARGENZA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "6a6d50c7-06ea-479c-83cc-f197a9e428c9", "openfda": {"nui": ["N0000175661", "N0000020008"], "upc": ["0374527022020"], "unii": ["K911R84KEW"], "rxcui": ["2474028", "2474033"], "spl_set_id": ["6a6d50c7-06ea-479c-83cc-f197a9e428c9"], "pharm_class_epc": ["HER2/neu Receptor Antagonist [EPC]"], "pharm_class_moa": ["HER2/Neu/cerbB2 Antagonists [MoA]"], "manufacturer_name": ["TerSera Therapeutics LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "MARGENZA", "product_id": "70720-022_6a6d50c7-06ea-479c-83cc-f197a9e428c9", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["HER2/Neu/cerbB2 Antagonists [MoA]", "HER2/neu Receptor Antagonist [EPC]"], "product_ndc": "70720-022", "generic_name": "margetuximab-cmkb", "labeler_name": "TerSera Therapeutics LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MARGENZA", "active_ingredients": [{"name": "MARGETUXIMAB", "strength": "25 mg/mL"}], "application_number": "BLA761150", "marketing_category": "BLA", "marketing_start_date": "20210115", "listing_expiration_date": "20261231"}