FDA.reportPublic FDA data

MARGENZA

Product NDC
74527-022
Requested package NDC
74527-022-03
11-digit product format
745270022
Labeler code
74527
Product ID
74527-022_97ee3be5-cd7f-45d4-85c7-b48ad596e837
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
margetuximab-cmkb
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
MacroGenics, Inc
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
e97a5872-eabf-463b-8f4c-5b5aed9c7bf0Available 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
74527-022-01MARGENZA10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE106
74527-022-02MARGENZA1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE16
74527-022-03MARGENZA4 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE46

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
74527-022-01ML - Milliliter74527-0225df5068c-1048-4f08-9897-00b6bc195fa012021-04-08
74527-022-02ML - Milliliter74527-0227ed55bb8-7914-4b53-97a3-1acc4e9d4f8712021-03-02
74527-022-03ML - Milliliter74527-0228cb4c700-e71c-415c-b8ee-44f72a815d9812021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74527-022MARGENZA (MARGETUXIMAB-CMKB) INJECTION, SOLUTION, CONCENTRATE [MACROGENICS, INC]6Current NDC, Legacy NDC, 3 package rows20250125_e97a5872-eabf-463b-8f4c-5b5aed9c7bf0.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
MARGENZAMARGETUXIMAB-CMKBMacroGenics, Ince97a5872-eabf-463b-8f4c-5b5aed9c7bf02025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761150
ndc (package): 74527-022-03
ndc (product): 74527-022
ndc11 (package): 74527002203

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 InjectionPSNe97a5872-eabf-463b-8f4c-5b5aed9c7bf06
2474028margetuximab-cmkb 250 MG in 10 ML InjectionPSNe97a5872-eabf-463b-8f4c-5b5aed9c7bf06
247403310 ML margetuximab-cmkb 25 MG/ML Injection [Margenza]SBDe97a5872-eabf-463b-8f4c-5b5aed9c7bf06
247402810 ML margetuximab-cmkb 25 MG/ML InjectionSCDe97a5872-eabf-463b-8f4c-5b5aed9c7bf06
247403310 ML Margenza 25 MG/ML InjectionSYe97a5872-eabf-463b-8f4c-5b5aed9c7bf06
2474033Margenza 250 MG per 10 ML InjectionSYe97a5872-eabf-463b-8f4c-5b5aed9c7bf06
2474028margetuximab-cmkb 250 MG per 10 ML InjectionSYe97a5872-eabf-463b-8f4c-5b5aed9c7bf06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
74527-022-03745270022034 VIAL, SINGLE-DOSE in 1 CARTON (74527-022-03) / 10 mL in 1 VIAL, SINGLE-DOSE (74527-022-01) 2021-01-150000-00-00NoNoCurrent