margenza

Generic: margetuximab-cmkb

Labeler: macrogenics, inc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name margenza
Generic Name margetuximab-cmkb
Labeler macrogenics, inc
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

margetuximab 25 mg/mL

Manufacturer
MacroGenics, Inc

Identifiers & Regulatory

Product NDC 74527-022
Product ID 74527-022_97ee3be5-cd7f-45d4-85c7-b48ad596e837
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 74527022
Hyphenated Format 74527-022

Supplemental Identifiers

RxCUI
2474028 2474033
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
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (74527-022-02) / 10 mL in 1 VIAL, SINGLE-DOSE (74527-022-01)
  • 4 VIAL, SINGLE-DOSE in 1 CARTON (74527-022-03) / 10 mL in 1 VIAL, SINGLE-DOSE (74527-022-01)
source: ndc

Packages (2)

74527-022-02 1 VIAL, SINGLE-DOSE in 1 CARTON (74527-022-02) / 10 mL in 1 VIAL, SINGLE-DOSE (74527-022-01) 74527-022-03 4 VIAL, SINGLE-DOSE in 1 CARTON (74527-022-03) / 10 mL in 1 VIAL, SINGLE-DOSE (74527-022-01)

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": "97ee3be5-cd7f-45d4-85c7-b48ad596e837", "openfda": {"nui": ["N0000175661", "N0000020008"], "unii": ["K911R84KEW"], "rxcui": ["2474028", "2474033"], "spl_set_id": ["e97a5872-eabf-463b-8f4c-5b5aed9c7bf0"], "pharm_class_epc": ["HER2/neu Receptor Antagonist [EPC]"], "pharm_class_moa": ["HER2/Neu/cerbB2 Antagonists [MoA]"], "manufacturer_name": ["MacroGenics, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (74527-022-02)  / 10 mL in 1 VIAL, SINGLE-DOSE (74527-022-01)", "package_ndc": "74527-022-02", "marketing_start_date": "20210115"}, {"sample": false, "description": "4 VIAL, SINGLE-DOSE in 1 CARTON (74527-022-03)  / 10 mL in 1 VIAL, SINGLE-DOSE (74527-022-01)", "package_ndc": "74527-022-03", "marketing_start_date": "20210115"}], "brand_name": "MARGENZA", "product_id": "74527-022_97ee3be5-cd7f-45d4-85c7-b48ad596e837", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["HER2/Neu/cerbB2 Antagonists [MoA]", "HER2/neu Receptor Antagonist [EPC]"], "product_ndc": "74527-022", "generic_name": "margetuximab-cmkb", "labeler_name": "MacroGenics, Inc", "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"}