FDA.reportPublic FDA data

Rybrevant

Product NDC
57894-501
Requested package NDC
57894-501-01
11-digit product format
578940501
Labeler code
57894
Product ID
57894-501_504da886-86ad-400c-8f0c-e503497de5e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amivantamab-vmjw
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Janssen Biotech, Inc.
Application
BLA761210
Marketing category
BLA
Marketing start
2021-05-21
Substance
AMIVANTAMAB
Active strength
350 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rybrevant
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMIVANTAMAB350 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0JSR7Z0NB6Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2549734Internal RxNorm lookup
2549739Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1466c070-9f97-4fa4-a955-6a6b59981fb8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fba5a780-b52d-4964-b662-1526b044aec4Product name120260127
4da1cc6f-1454-4667-9e32-0182fda070c5Product name120211209
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57894-501-00Rybrevant1 in 1 VIAL, SINGLE-USEINJECTION116
57894-501-01Rybrevant1 in 1 CARTONINJECTION116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57894-501-00ML - Milliliter57894-501e9e1ec26-c9ee-44ed-a738-e8ac33b5f84012021-06-02
57894-501-01ML - Milliliter57894-50178691979-247d-47db-9512-a0131a03779e12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57894-501RYBREVANT (AMIVANTAMAB) INJECTION [JANSSEN BIOTECH, INC.]10Current NDC, Legacy NDC, 2 package rows20250228_1466c070-9f97-4fa4-a955-6a6b59981fb8.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RybrevantAMIVANTAMAB-VMJWJanssen Biotech, Inc.1466c070-9f97-4fa4-a955-6a6b59981fb82025-11-11Warnings, Adverse reactionsExact identifier
application number: BLA761210
ndc (package): 57894-501-01
ndc (product): 57894-501
ndc11 (package): 57894050101

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761210Rybrevantamivantamab-vmjw351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2549734amivantamab-vmjw 350 MG in 7 ML InjectionPSN1466c070-9f97-4fa4-a955-6a6b59981fb816
2549739Rybrevant 350 MG in 7 ML InjectionPSN1466c070-9f97-4fa4-a955-6a6b59981fb816
25497397 ML amivantamab-vmjw 50 MG/ML Injection [Rybrevant]SBD1466c070-9f97-4fa4-a955-6a6b59981fb816
25497347 ML amivantamab-vmjw 50 MG/ML InjectionSCD1466c070-9f97-4fa4-a955-6a6b59981fb816
2549734amivantamab-vmjw 350 MG per 7 ML InjectionSY1466c070-9f97-4fa4-a955-6a6b59981fb816
2549734amivantamab-vmjw 50 MG/ML per 7 ML InjectionSY1466c070-9f97-4fa4-a955-6a6b59981fb816
2549739Rybrevant 350 MG per 7 ML InjectionSY1466c070-9f97-4fa4-a955-6a6b59981fb816
2549739Rybrevant 50 MG/ML per 7 ML InjectionSY1466c070-9f97-4fa4-a955-6a6b59981fb816

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57894-501-01578940501011 VIAL, SINGLE-USE in 1 CARTON (57894-501-01) / 1 INJECTION in 1 VIAL, SINGLE-USE (57894-501-00) 2021-05-210000-00-00NoNoCurrent