FDA.reportPublic FDA data

NDC 83564-110-01 - Symvess

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
83564-110
Requested NDC
83564-110-01
Package NDCs from labels
83564-110-01, 83564-110-00
Manufacturer
Humacyte Global, Inc.
Effective date
2025-12-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Symvess - Humacyte Global, Inc.Humacyte Global, Inc.2025-12-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83564-110-00Symvess1 in 1 BAGIMPLANT12
83564-110-01Symvess1 in 1 BOXIMPLANT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83564-110SYMVESS (ACELLULAR TISSUE ENGINEERED VESSEL) IMPLANT [HUMACYTE GLOBAL, INC.]1Current NDC, 2 package rows20241228_15e9e29f-5aa6-4fc6-b0fe-a48cd1473418.zip

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 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SymvessACELLULAR TISSUE ENGINEERED VESSELHumacyte Global, Inc.15e9e29f-5aa6-4fc6-b0fe-a48cd14734182025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125812
ndc (package): 83564-110-00
ndc (package): 83564-110-01
ndc (product): 83564-110
ndc11 (package): 83564011001
rxcui: 2700346
rxcui: 2700352
spl id: 2ca3c2b8-a86b-4e5e-894a-6529e03052e0
spl set id: 15e9e29f-5aa6-4fc6-b0fe-a48cd1473418
unii: 6H248RS8YQ

Reported adverse events (FAERS/openFDA)#

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