FDA.reportPublic FDA data

MARGENZA

Product NDC
70720-022
11-digit product format
707200022
Labeler code
70720
Product ID
70720-022_6a6d50c7-06ea-479c-83cc-f197a9e428c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
margetuximab-cmkb
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
TerSera Therapeutics LLC
Application
BLA761150
Marketing category
BLA
Marketing start
2021-01-15
Substance
MARGETUXIMAB
Active strength
25 mg/mL
Pharmacologic classes
HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
MARGENZA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MARGETUXIMAB25 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K911R84KEWInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2474028Internal RxNorm lookup
2474033Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6a6d50c7-06ea-479c-83cc-f197a9e428c9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
896bf36c-d165-43aa-8d09-c4a4712f6d5cProduct name120210607
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70720-022-01MARGENZA10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE101
70720-022-02MARGENZA1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE11
70720-022-03MARGENZA4 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70720-022MARGENZA (MARGETUXIMAB-CMKB) INJECTION, SOLUTION, CONCENTRATE [TERSERA THERAPEUTICS LLC]1Current NDC, 3 package rows20250224_6a6d50c7-06ea-479c-83cc-f197a9e428c9.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MARGENZAMARGETUXIMAB-CMKBTerSera Therapeutics LLC6a6d50c7-06ea-479c-83cc-f197a9e428c92025-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761150
ndc (product): 70720-022
MARGENZAMARGETUXIMAB-CMKBMacroGenics, Ince97a5872-eabf-463b-8f4c-5b5aed9c7bf02025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761150

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761150Margenzamargetuximab-cmkb351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2474033Margenza 250 MG in 10 ML InjectionPSN6a6d50c7-06ea-479c-83cc-f197a9e428c91
2474028margetuximab-cmkb 250 MG in 10 ML InjectionPSN6a6d50c7-06ea-479c-83cc-f197a9e428c91
247403310 ML margetuximab-cmkb 25 MG/ML Injection [Margenza]SBD6a6d50c7-06ea-479c-83cc-f197a9e428c91
247402810 ML margetuximab-cmkb 25 MG/ML InjectionSCD6a6d50c7-06ea-479c-83cc-f197a9e428c91
247403310 ML Margenza 25 MG/ML InjectionSY6a6d50c7-06ea-479c-83cc-f197a9e428c91
2474033Margenza 250 MG per 10 ML InjectionSY6a6d50c7-06ea-479c-83cc-f197a9e428c91
2474028margetuximab-cmkb 250 MG per 10 ML InjectionSY6a6d50c7-06ea-479c-83cc-f197a9e428c91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
70720-022-017072000220110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
70720-022-02707200022021 in 1 CARTONHistorical
70720-022-03707200022034 in 1 CARTONHistorical