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 Identifiers#

Field, Values table
FieldValues
Unii6H248RS8YQ
Rxcui2700346, 2700352

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

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 box2024-12-19NoNoHistorical
83564-110-01835640110011 in 1 BOXHistorical