FDA.reportPublic FDA data

Enspryng

Product NDC
50242-005
Requested package NDC
50242-005-01
11-digit product format
502420005
Labeler code
50242
Product ID
50242-005_63a8ff00-ffa2-4f6f-84fb-338e7aa7c160
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Satralizumab
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Genentech, Inc.
Application
BLA761149
Marketing category
BLA
Marketing start
2026-10-15
Substance
SATRALIZUMAB
Active strength
180 mg/1.5mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Enspryng
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SATRALIZUMAB180 mg/1.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YB18NF020MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2391555Internal RxNorm lookup
2391560Internal RxNorm lookup
2755191Internal RxNorm lookup
2755195Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
64c156a4-9bad-4d45-a294-0733c141f47bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8721f224-3ae0-4979-9795-959bcbd02e49Product name120210309
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761149Enspryngsatralizumab-mwge351(a)Rx2026-10-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2391560Enspryng 120 MG in 1 ML Prefilled SyringePSN64c156a4-9bad-4d45-a294-0733c141f47b13
2391555satralizumab-mwge 120 MG in 1 ML Prefilled SyringePSN64c156a4-9bad-4d45-a294-0733c141f47b13
23915601 ML satralizumab-mwge 120 MG/ML Prefilled Syringe [Enspryng]SBD64c156a4-9bad-4d45-a294-0733c141f47b13
23915551 ML satralizumab-mwge 120 MG/ML Prefilled SyringeSCD64c156a4-9bad-4d45-a294-0733c141f47b13
23915601 ML Enspryng 120 MG/ML Prefilled SyringeSY64c156a4-9bad-4d45-a294-0733c141f47b13
2391560Enspryng 120 MG per 1 ML Prefilled SyringeSY64c156a4-9bad-4d45-a294-0733c141f47b13
2391555satralizumab-mwge 120 MG per 1 ML Prefilled SyringeSY64c156a4-9bad-4d45-a294-0733c141f47b13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50242-005-01502420005011 SYRINGE, PLASTIC in 1 CARTON (50242-005-01) / 1.5 mL in 1 SYRINGE, PLASTIC2026-10-15NoNoCurrent