NDC 50222-362-12 - SPEVIGO

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 50222-362
Requested NDC: 50222-362-12
Package NDCs from labels: 50222-362-12, 50222-362-01, 50222-362-02
Manufacturer: LEO Pharma Inc. | Boehringer Ingelheim Pharma GmbH and Co. KG | West-Ward Columbus Inc.
Effective date: 2026-03-16
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
SPEVIGO	LEO Pharma Inc. \| Boehringer Ingelheim Pharma GmbH and Co. KG \| West-Ward Columbus Inc.	2026-03-16	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50222-362-01	SPEVIGO	1 in 1 CARTON	INJECTION	1	2
50222-362-02	SPEVIGO	2 in 1 CARTON	INJECTION	2	2
50222-362-12	SPEVIGO	2 mL in 1 SYRINGE, GLASS	INJECTION	2	2

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SPEVIGO	SPESOLIMAB-SBZO	Boehringer Ingelheim Pharmaceuticals, Inc.	41a481ee-3062-45d1-aed5-17e8b105634d	2026-04-08	Warnings, Adverse reactions	Exact identifier application number: BLA761244 rxcui: 2610428 rxcui: 2610422 rxcui: 2716697 rxcui: 2678984 rxcui: 2716696 rxcui: 2678979 unii: 5IB2J79MCX
SPEVIGO	SPESOLIMAB	LEO Pharma Inc.	78a4f7eb-8d34-4467-8d40-74ed24323806	2026-03-16	Warnings, Adverse reactions	Exact identifier application number: BLA761244 ndc (package): 50222-360-72 ndc (package): 50222-362-12 ndc (package): 50222-361-11 ndc (package): 50222-361-02 ndc (package): 50222-362-01 ndc (package): 50222-362-02 ndc (product): 50222-361 ndc (product): 50222-360 ndc (product): 50222-362 ndc11 (package): 50222036212 rxcui: 2610428 rxcui: 2610422 rxcui: 2716697 rxcui: 2678984 rxcui: 2716696 rxcui: 2678979 spl id: 40cef378-e90e-4891-812a-b3c889dc9193 spl set id: 78a4f7eb-8d34-4467-8d40-74ed24323806 unii: 5IB2J79MCX

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.