FDA.reportPublic FDA data

EVARREST

Product NDC
63713-050
11-digit product format
637130050
Labeler code
63713
Product ID
63713-050_2dcbcc7a-19d2-db46-e063-6394a90a6b9b
Type
PLASMA DERIVATIVE
Nonproprietary name
Fibrinogen Human and Human Thrombin
Dosage form
PATCH
Route
TOPICAL
Labeler
Ethicon, Inc.
Application
BLA125392
Marketing category
BLA
Marketing start
2013-03-01
Substance
FIBRINOGEN HUMAN; HUMAN THROMBIN
Active strength
8.6; 37.5 mg/cm2; [iU]/cm2
Pharmacologic classes
Blood Coagulation Factors [CS], Blood Coagulation Factors [CS], Human Blood Coagulation Factor [EPC], Human Blood Coagulation Factor [EPC], Increased Coagulation Activity [PE], Increased Coagulation Factor Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FIBRINOGEN HUMAN8.6 mg/cm2
HUMAN THROMBIN37.5 [iU]/cm2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63713-050-24EVARREST2 in 1 CARTONPATCH214
63713-050-25EVARREST52 cm2 in 1 TRAYPATCH5214
63713-050-25EVARREST1 in 1 POUCHPATCH114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63713-050-24EA - Each63713-0507bca1c10-c373-4b10-8b5b-7f9eac3547b412025-06-13
63713-050-25EA - Each63713-050ee5aa25f-802e-4ddf-b890-c1f67240491c12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63713-050EVARREST (FIBRINOGEN HUMAN AND HUMAN THROMBIN) PATCH [ETHICON, INC.]14Current NDC, Legacy NDC, 3 package rows20250212_92371a00-4bbd-4815-86dd-bae1505d0c2f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1793135EVARREST 2 inch x 4 inch Medicated PatchPSN92371a00-4bbd-4815-86dd-bae1505d0c2f14
1793130fibrinogen / thrombin (human) 2 inch x 4 inch Medicated PatchPSN92371a00-4bbd-4815-86dd-bae1505d0c2f14
1793135fibrinogen, human 444 MG / thrombin, human 1935 UNT Medicated Patch [EVARREST]SBD92371a00-4bbd-4815-86dd-bae1505d0c2f14
1793130fibrinogen, human 444 MG / thrombin, human 1935 UNT Medicated PatchSCD92371a00-4bbd-4815-86dd-bae1505d0c2f14
1793135EVARREST (fibrinogen, human 444 MG / thrombin, human 1935 UNT) Medicated PatchSY92371a00-4bbd-4815-86dd-bae1505d0c2f14
1793135EVARREST 2 inch x 4 inch Medicated PatchSY92371a00-4bbd-4815-86dd-bae1505d0c2f14
1793130fibrinogen, human / thrombin, human 2 inch x 4 inch Medicated PatchSY92371a00-4bbd-4815-86dd-bae1505d0c2f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63713-050-24637130050242 POUCH in 1 CARTON (63713-050-24) / 1 TRAY in 1 POUCH (63713-050-25) / 52 cm2 in 1 TRAY2 pouch2013-03-010000-00-00NoNoCurrent
63713-050-256371300502552 cm2 in 1 TRAY52 cm2Historical