FDA.reportPublic FDA data

VOYXACT

Product NDC
59148-400
11-digit product format
591480400
Labeler code
59148
Product ID
59148-400_9aa886b0-669e-48d4-9f37-a160d78f69c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sibeprenlimab
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Otsuka America Pharmaceutical, Inc.
Application
BLA761434
Marketing category
BLA
Marketing start
2025-11-25
Substance
SIBEPRENLIMAB
Active strength
200 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SIBEPRENLIMAB200 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
GHX28QZ7DDInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2728400Internal RxNorm lookup
2728407Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c8a93b32-0676-4704-86dc-cb65f425c6e5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
59148-400-75VOYXACT2 mL in 1 SYRINGEINJECTION23
59148-400-75VOYXACT1 in 1 CARTONINJECTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59148-400-75ML - Milliliter59148-400781b2b68-aece-43ad-bb94-8950765da17d12026-01-08

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
VOYXACTSIBEPRENLIMABOtsuka America Pharmaceutical, Inc.c8a93b32-0676-4704-86dc-cb65f425c6e52026-03-17Warnings, Adverse reactionsExact identifier
application number: BLA761434
ndc (product): 59148-400

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761434Voyxactsibeprenlimab-szsi351(a)Rx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2728400sibeprenlimab-szsi 400 MG in 2 ML Prefilled SyringePSNc8a93b32-0676-4704-86dc-cb65f425c6e53
2728407Voyxact 400 MG in 2 ML Prefilled SyringePSNc8a93b32-0676-4704-86dc-cb65f425c6e53
27284072 ML sibeprenlimab-szsi 200 MG/ML Prefilled Syringe [Voyxact]SBDc8a93b32-0676-4704-86dc-cb65f425c6e53
27284002 ML sibeprenlimab-szsi 200 MG/ML Prefilled SyringeSCDc8a93b32-0676-4704-86dc-cb65f425c6e53
2728400sibeprenlimab-szsi 400 MG per 2 ML Prefilled SyringeSYc8a93b32-0676-4704-86dc-cb65f425c6e53
2728407Voyxact 400 MG per 2 ML Prefilled SyringeSYc8a93b32-0676-4704-86dc-cb65f425c6e53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59148-400-75591480400751 SYRINGE in 1 CARTON (59148-400-75) / 2 mL in 1 SYRINGE1 syringe2025-11-25NoNoCurrent