FDA.reportPublic FDA data

Enspryng

Product NDC
50242-007
11-digit product format
502420007
Labeler code
50242
Product ID
50242-007_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
2020-08-14
Substance
SATRALIZUMAB
Active strength
120 mg/mL
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
SATRALIZUMAB120 mg/mL

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50242-007-01Enspryng1 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION113
50242-007-01Enspryng1 in 1 CARTONINJECTION, SOLUTION113
50242-007-86Enspryng1 in 1 CARTONINJECTION, SOLUTION113
50242-007-86Enspryng1 mL in 1 SYRINGE, PLASTICINJECTION, SOLUTION113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-007-01ML - Milliliter50242-007e41090d3-791a-4f47-bcef-23ae4898c7d512020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-007ENSPRYNG (SATRALIZUMAB) INJECTION, SOLUTION [GENENTECH INC.]10Current NDC, Legacy NDC, 4 package rows20250515_64c156a4-9bad-4d45-a294-0733c141f47b.zip

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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50242-007-01502420007011 SYRINGE, PLASTIC in 1 CARTON (50242-007-01) / 1 mL in 1 SYRINGE, PLASTIC2020-08-140000-00-00NoNoCurrent
50242-007-33502420007331 SYRINGE in 1 CARTON (50242-007-33) / 1 mL in 1 SYRINGE1 syringe2026-06-10YesNoCurrent
50242-007-55502420007551 SYRINGE, PLASTIC in 1 CARTON (50242-007-55) / 1 mL in 1 SYRINGE, PLASTIC2026-06-10NoNoCurrent
50242-007-86502420007861 SYRINGE, PLASTIC in 1 CARTON (50242-007-86) / 1 mL in 1 SYRINGE, PLASTIC2021-08-130000-00-00YesNoCurrent