NDC 0597-0620-10 - 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: 0597-0620
Requested NDC: 0597-0620-10
Package NDCs from labels: 0597-0620-10, 0597-0620-20
Manufacturer: Boehringer Ingelheim Pharmaceuticals, Inc. | Boehringer Ingelheim Pharma GmbH and Co. KG | West-Ward Columbus Inc.
Effective date: 2026-04-08
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
SPEVIGO	Boehringer Ingelheim Pharmaceuticals, Inc. \| Boehringer Ingelheim Pharma GmbH and Co. KG \| West-Ward Columbus Inc.	2026-04-08	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0597-0620-10	SPEVIGO	150 mL in 1 SYRINGE	INJECTION	150		6
0597-0620-20	SPEVIGO	2 in 1 CARTON	INJECTION	2		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0597-0620	SPEVIGO (SPESOLIMAB-SBZO) INJECTION [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	4	Current NDC, 2 package rows	20241215_41a481ee-3062-45d1-aed5-17e8b105634d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0597-0620-10	ML - Milliliter	0597-0620	c50ffed1-6388-4615-aba2-253b02f468e2	1	2025-01-14
0597-0620-20	ML - Milliliter	0597-0620	4ce941d6-0736-4802-b5b3-d150e21f5097	1	2024-05-16

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 ndc (package): 0597-0620-20 ndc (package): 0597-0620-10 ndc (package): 0597-0035-10 ndc (package): 0597-7705-72 ndc (package): 0597-7705-38 ndc (package): 0597-7705-41 ndc (product): 0597-7705 ndc (product): 0597-0620 ndc (product): 0597-0035 ndc11 (package): 00597062010 rxcui: 2610428 rxcui: 2610422 rxcui: 2716697 rxcui: 2678984 rxcui: 2716696 rxcui: 2678979 spl id: 021b29b5-64ea-411e-91a8-c1f5015c3d9c spl set id: 41a481ee-3062-45d1-aed5-17e8b105634d unii: 5IB2J79MCX
SPEVIGO	SPESOLIMAB	LEO Pharma Inc.	78a4f7eb-8d34-4467-8d40-74ed24323806	2026-03-16	Warnings, Adverse reactions	Exact identifier application number: BLA761244 rxcui: 2610428 rxcui: 2610422 rxcui: 2716697 rxcui: 2678984 rxcui: 2716696 rxcui: 2678979 unii: 5IB2J79MCX

Reported adverse events (FAERS/openFDA)#

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