FDA.reportPublic FDA data

Avance Nerve Graft

Product NDC
84545-430
11-digit product format
845450430
Labeler code
84545
Product ID
84545-430_5c0c36c2-0dcf-4762-8653-31805880f668
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Processed nerve allograft
Dosage form
IMPLANT
Route
SOFT TISSUE
Labeler
Axogen Corporation
Application
BLA125816
Marketing category
BLA
Marketing start
2026-04-06
Substance
HUMAN PERIPHERAL NERVE TISSUE
Active strength
4 mm/30mm
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Avance Nerve Graft
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HUMAN PERIPHERAL NERVE TISSUE4 mm/30mm

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
725P2LR8RGInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e50d90fa-83ef-4d1b-9691-2b9c7bbdc2aeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84545-430-01Avance Nerve Graft1 in 1 BAGIMPLANT13
84545-430-01Avance Nerve Graft1 in 1 CARTONIMPLANT13

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
Avance Nerve GraftPROCESSED NERVE ALLOGRAFTAxogen Corporatione50d90fa-83ef-4d1b-9691-2b9c7bbdc2ae2026-01-23Warnings, Adverse reactionsExact identifier
application number: BLA125816
ndc (product): 84545-430

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125816avance nerve graftacellular nerve allograft-arwx351(a)Rx2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84545-430-01845450430011 CARTON in 1 BAG (84545-430-01) / 1 POUCH in 1 CARTON / 1 POUCH in 1 POUCH / 1 CONTAINER in 1 POUCH / 1 mm in 1 CONTAINER1 carton2026-04-06NoNoCurrent