FDA.reportPublic FDA data

MARGENZA

Product NDC
74527-022
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 (product): 74527-022

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761150Margenzamargetuximab-cmkb351(a)Rx2026-06-01

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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
74527-022-017452700220110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
74527-022-02745270022021 VIAL, SINGLE-DOSE in 1 CARTON (74527-022-02) / 10 mL in 1 VIAL, SINGLE-DOSE (74527-022-01) 2021-01-150000-00-00NoNoCurrent
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