Home NDC 83564-110 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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Symvess ACELLULAR TISSUE ENGINEERED VESSEL Humacyte Global, Inc. 15e9e29f-5aa6-4fc6-b0fe-a48cd1473418 2025-12-09 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125812 ndc (product): 83564-110
Additional Listing Data#
Finished product Yes
Brand name base Symvess
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACELLULAR TISSUE ENGINEERED VESSEL 420 mm/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6H248RS8YQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2700346 Internal RxNorm lookup 2700352 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83564-110-00 Symvess 1 in 1 BAG IMPLANT 1 2 83564-110-01 Symvess 1 in 1 BOX IMPLANT 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83564-110 SYMVESS (ACELLULAR TISSUE ENGINEERED VESSEL) IMPLANT [HUMACYTE GLOBAL, INC.] 1 Current NDC, 2 package rows 20241228_15e9e29f-5aa6-4fc6-b0fe-a48cd1473418.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125812 symvess acellular tissue engineered vessel-tyod 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83564-110-00 83564011000 1 BOX in 1 BAG (83564-110-00) / 1 IMPLANT in 1 BOX (83564-110-01) 1 box 2024-12-19 No No Current 83564-110-01 83564011001 1 in 1 BOX Historical