FDA.reportPublic FDA data

Enjaymo

Product NDC
80203-347
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct80203-347IInactivated by FDA2026-07-31
excluded packagepackage80203-34780203-347-01IInactivated by FDA2026-07-31

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 · 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

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761164Enjaymosutimlimab-jome351(a)Rx2026-06-01

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