FDA.reportPublic FDA data

Enjaymo

Product NDC
80203-347
Requested package NDC
80203-347-01
11-digit product format
802030347
Labeler code
80203
Product ID
80203-347_6b1f36e8-41c9-4d12-b265-49c9d819c58b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sutimlimab-jome
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Bioverativ U.S. LLC.
Application
BLA761164
Marketing category
BLA
Marketing start
2022-02-04
Marketing end
0000-00-00
Substance
SUTIMLIMAB
Active strength
50 mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage80203-34780203-347-01IInactivated by FDA2026-09-14

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
e6cbb96b-35e9-474e-8a61-9808119fc281Product name120221116
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80203-347-01Enjaymo22 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE2210
80203-347-01Enjaymo1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80203-347-01ML - Milliliter80203-34778e506df-bd60-4033-8502-98f9282f555812022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80203-347ENJAYMO (SUTIMLIMAB-JOME) INJECTION, SOLUTION, CONCENTRATE [BIOVERATIV THERAPEUTICS INC.]10Legacy NDC, 2 package rows20240511_281cf1d4-6296-4416-858e-9bff46d01b71.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
EnjaymoSUTIMLIMAB-JOMERecordati Rare Diseases, Inc.0a25363a-7781-d9f8-cb1c-be22987bf03b2026-03-02Warnings, Adverse reactionsExact identifier
application number: BLA761164

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761164Enjaymosutimlimab-jome351(a)Rx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2591425Enjaymo 1100 MG in 22 ML InjectionPSN281cf1d4-6296-4416-858e-9bff46d01b7110
2591419sutimlimab-jome 1100 MG in 22 ML InjectionPSN281cf1d4-6296-4416-858e-9bff46d01b7110
259142522 ML sutimlimab-jome 50 MG/ML Injection [Enjaymo]SBD281cf1d4-6296-4416-858e-9bff46d01b7110
259141922 ML sutimlimab-jome 50 MG/ML InjectionSCD281cf1d4-6296-4416-858e-9bff46d01b7110
259142522 ML Enjaymo 50 MG/ML InjectionSY281cf1d4-6296-4416-858e-9bff46d01b7110
2591425Enjaymo 1100 MG per 22 ML InjectionSY281cf1d4-6296-4416-858e-9bff46d01b7110
2591419sutimlimab-jome 1100 MG per 22 ML InjectionSY281cf1d4-6296-4416-858e-9bff46d01b7110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
80203-347-01802030347011 VIAL, SINGLE-DOSE in 1 CARTON (80203-347-01) > 22 mL in 1 VIAL, SINGLE-DOSE2022-02-040000-00-00NoNoCurrent