FDA.reportPublic FDA data

Symvess

Product NDC
83564-110
11-digit product format
835640110
Labeler code
83564
Product ID
83564-110_2ca3c2b8-a86b-4e5e-894a-6529e03052e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACELLULAR TISSUE ENGINEERED VESSEL
Dosage form
IMPLANT
Route
INTRAVASCULAR
Labeler
Humacyte Global, Inc.
Application
BLA125812
Marketing category
BLA
Marketing start
2024-12-19
Substance
ACELLULAR TISSUE ENGINEERED VESSEL
Active strength
420 mm/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Symvess
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACELLULAR TISSUE ENGINEERED VESSEL420 mm/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6H248RS8YQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2700346Internal RxNorm lookup
2700352Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15e9e29f-5aa6-4fc6-b0fe-a48cd1473418Available on FDA.report

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 · 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 (product): 83564-110

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125812symvessacellular tissue engineered vessel-tyod351(a)Rx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2700346acellular tissue engineered vessel-tyod Vascular ImplantPSN15e9e29f-5aa6-4fc6-b0fe-a48cd14734182
2700352Symvess Vascular ImplantPSN15e9e29f-5aa6-4fc6-b0fe-a48cd14734182
2700352acellular tissue engineered vessel-tyod 40 CM Drug Implant [Symvess]SBD15e9e29f-5aa6-4fc6-b0fe-a48cd14734182
2700346acellular tissue engineered vessel-tyod 40 CM Drug ImplantSCD15e9e29f-5aa6-4fc6-b0fe-a48cd14734182
2700346acellular tissue engineered vessel-tyod Vascular ImplantSY15e9e29f-5aa6-4fc6-b0fe-a48cd14734182
2700352Symvess (acellular tissue engineered vessel-tyod) Vascular ImplantSY15e9e29f-5aa6-4fc6-b0fe-a48cd14734182
2700352Symvess 40 CM Vascular ImplantSY15e9e29f-5aa6-4fc6-b0fe-a48cd14734182
2700352Symvess Vascular ImplantSY15e9e29f-5aa6-4fc6-b0fe-a48cd14734182

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83564-110-00835640110001 BOX in 1 BAG (83564-110-00) / 1 IMPLANT in 1 BOX (83564-110-01) 1 box2024-12-19NoNoCurrent
83564-110-01835640110011 in 1 BOXHistorical