spevigo

Generic: spesolimab-sbzo

Labeler: boehringer ingelheim pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name spevigo
Generic Name spesolimab-sbzo
Labeler boehringer ingelheim pharmaceuticals, inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

spesolimab 60 mg/mL

Manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0597-0035
Product ID 0597-0035_31184b4e-682f-45ba-9e4f-332bc1df45b8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761244
Listing Expiration 2026-12-31
Marketing Start 2022-09-01

Pharmacologic Class

Established (EPC)
interleukin-36 receptor antagonist [epc]
Mechanism of Action
interleukin-36 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05970035
Hyphenated Format 0597-0035

Supplemental Identifiers

RxCUI
2610422 2610428 2678979 2678984 2716696 2716697
UPC
0305970035107
UNII
5IB2J79MCX
NUI
N0000194039 N0000194040

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 spevigo (source: ndc)
Generic Name spesolimab-sbzo (source: ndc)
Application Number BLA761244 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 60 mg/mL
source: ndc
Packaging
  • 2 VIAL, GLASS in 1 CARTON (0597-0035-10) / 7.5 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

0597-0035-10 2 VIAL, GLASS in 1 CARTON (0597-0035-10) / 7.5 mL in 1 VIAL, GLASS

Ingredients (1)

spesolimab (60 mg/mL)

Linked Drug Pages (1)

SPEVIGO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "31184b4e-682f-45ba-9e4f-332bc1df45b8", "openfda": {"nui": ["N0000194039", "N0000194040"], "upc": ["0305970035107"], "unii": ["5IB2J79MCX"], "rxcui": ["2610422", "2610428", "2678979", "2678984", "2716696", "2716697"], "spl_set_id": ["41a481ee-3062-45d1-aed5-17e8b105634d"], "pharm_class_epc": ["Interleukin-36 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Interleukin-36 Receptor Antagonists [MoA]"], "manufacturer_name": ["Boehringer Ingelheim Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 VIAL, GLASS in 1 CARTON (0597-0035-10)  / 7.5 mL in 1 VIAL, GLASS", "package_ndc": "0597-0035-10", "marketing_start_date": "20220901"}], "brand_name": "SPEVIGO", "product_id": "0597-0035_31184b4e-682f-45ba-9e4f-332bc1df45b8", "dosage_form": "INJECTION", "pharm_class": ["Interleukin-36 Receptor Antagonist [EPC]", "Interleukin-36 Receptor Antagonists [MoA]"], "product_ndc": "0597-0035", "generic_name": "spesolimab-sbzo", "labeler_name": "Boehringer Ingelheim Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SPEVIGO", "active_ingredients": [{"name": "SPESOLIMAB", "strength": "60 mg/mL"}], "application_number": "BLA761244", "marketing_category": "BLA", "marketing_start_date": "20220901", "listing_expiration_date": "20261231"}