voyxact

Generic: sibeprenlimab

Labeler: otsuka america pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name voyxact
Generic Name sibeprenlimab
Labeler otsuka america pharmaceutical, inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

sibeprenlimab 200 mg/mL

Manufacturer
Otsuka America Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 59148-400
Product ID 59148-400_f3ee65b5-b628-443d-8a34-2e2f0d8f76d8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761434
Listing Expiration 2026-12-31
Marketing Start 2025-11-25

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59148400
Hyphenated Format 59148-400

Supplemental Identifiers

RxCUI
2728400 2728407
UNII
GHX28QZ7DD

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name voyxact (source: ndc)
Generic Name sibeprenlimab (source: ndc)
Application Number BLA761434 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (59148-400-75) / 2 mL in 1 SYRINGE
source: ndc

Packages (1)

59148-400-75 1 SYRINGE in 1 CARTON (59148-400-75) / 2 mL in 1 SYRINGE

Ingredients (1)

sibeprenlimab (200 mg/mL)

Linked Drug Pages (1)

VOYXACT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "f3ee65b5-b628-443d-8a34-2e2f0d8f76d8", "openfda": {"unii": ["GHX28QZ7DD"], "rxcui": ["2728400", "2728407"], "spl_set_id": ["c8a93b32-0676-4704-86dc-cb65f425c6e5"], "manufacturer_name": ["Otsuka America Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (59148-400-75)  / 2 mL in 1 SYRINGE", "package_ndc": "59148-400-75", "marketing_start_date": "20251125"}], "brand_name": "VOYXACT", "product_id": "59148-400_f3ee65b5-b628-443d-8a34-2e2f0d8f76d8", "dosage_form": "INJECTION", "product_ndc": "59148-400", "generic_name": "sibeprenlimab", "labeler_name": "Otsuka America Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VOYXACT", "active_ingredients": [{"name": "SIBEPRENLIMAB", "strength": "200 mg/mL"}], "application_number": "BLA761434", "marketing_category": "BLA", "marketing_start_date": "20251125", "listing_expiration_date": "20261231"}