FDA.reportPublic FDA data

Enspryng

Product NDC
50242-007
11-digit product format
502420007
Labeler code
50242
Product ID
50242-007_934d1456-ebad-46b5-8f09-ff9aed5e4e88
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SATRALIZUMAB120 mg/mL

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 · 2 matching rows.

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

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

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
EnspryngSATRALIZUMABGenentech, Inc.64c156a4-9bad-4d45-a294-0733c141f47b2026-06-22Warnings, Adverse reactionsExact identifier
application number: BLA761149
ndc (product): 50242-007

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761149Enspryngsatralizumab-mwge351(a)Rx2026-07-01

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 syringe2026-06-101Current
50242-007-55502420007551 SYRINGE, PLASTIC in 1 CARTON (50242-007-55) / 1 mL in 1 SYRINGE, PLASTIC2026-06-100Current
50242-007-86502420007861 SYRINGE, PLASTIC in 1 CARTON (50242-007-86) / 1 mL in 1 SYRINGE, PLASTIC2021-08-130000-00-00YesNoCurrent