FDA.reportPublic FDA data

GINTUIT

Product NDC
42606-004
11-digit product format
426060004
Labeler code
42606
Product ID
42606-004_499fd880-257d-49d2-972f-68be99d6e5cd
Type
CELLULAR THERAPY
Nonproprietary name
Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen
Dosage form
CELLULAR SHEET
Route
TOPICAL
Labeler
Organogenesis, Inc
Application
BLA125400
Marketing category
BLA
Marketing start
2012-03-15
Marketing end
0000-00-00
Substance
FORESKIN FIBROBLAST (NEONATAL); BOVINE TYPE I COLLAGEN; FORESKIN KERATINOCYTE (NEONATAL)
Active strength
0 /; /; /
Pharmacologic classes
Allogeneic Cultured Cell Scaffold [EPC],Collagen [CS],Allogeneic Cultured Cell Scaffold [EPC],Tissue Scaffolds [CS],Cells, Cultured, Allogeneic [EXT],Fibroblasts [CS],Allogeneic Cultured Cell Scaffold [EPC],Tissue Scaffolds [CS],Cells, Cultured, Allogeneic [EXT],Keratinocytes [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42606-004IInactivated by FDA2026-07-31
excluded packagepackage42606-00442606-004-01IInactivated by FDA2026-07-31

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42606-004-012019-11-13C16284748780-197449f38-bd86-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use GINTUIT safely and effectively. See full prescribing information for GINTUIT. GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen) Cellular Sheet for Topical Oral Application Initial U.S. Approval: 2012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42606-004-01GINTUIT44.2 cm2 in 1 TRAYCELLULAR SHEET44.22

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BOVINE TYPE I COLLAGENACTIVE INGREDIENTFHJ3ATL51CGINTUIT (ALLOGENEIC CULTURED KERATINOCYTES AND FIBROBLASTS IN BOVINE COLLAGEN) CELLULAR SHEET [ORGANOGENESIS, INC]2
FORESKIN FIBROBLAST (NEONATAL)ACTIVE INGREDIENTT34C307W5NGINTUIT (ALLOGENEIC CULTURED KERATINOCYTES AND FIBROBLASTS IN BOVINE COLLAGEN) CELLULAR SHEET [ORGANOGENESIS, INC]2
FORESKIN KERATINOCYTE (NEONATAL)ACTIVE INGREDIENTZJO8CP3Q2AGINTUIT (ALLOGENEIC CULTURED KERATINOCYTES AND FIBROBLASTS IN BOVINE COLLAGEN) CELLULAR SHEET [ORGANOGENESIS, INC]2
BOVINE TYPE I COLLAGENACTIVE MOIETYFHJ3ATL51CGINTUIT (ALLOGENEIC CULTURED KERATINOCYTES AND FIBROBLASTS IN BOVINE COLLAGEN) CELLULAR SHEET [ORGANOGENESIS, INC]2
FORESKIN FIBROBLAST (NEONATAL)ACTIVE MOIETYT34C307W5NGINTUIT (ALLOGENEIC CULTURED KERATINOCYTES AND FIBROBLASTS IN BOVINE COLLAGEN) CELLULAR SHEET [ORGANOGENESIS, INC]2
FORESKIN KERATINOCYTE (NEONATAL)ACTIVE MOIETYZJO8CP3Q2AGINTUIT (ALLOGENEIC CULTURED KERATINOCYTES AND FIBROBLASTS IN BOVINE COLLAGEN) CELLULAR SHEET [ORGANOGENESIS, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42606-004GINTUIT (ALLOGENEIC CULTURED KERATINOCYTES AND FIBROBLASTS IN BOVINE COLLAGEN) CELLULAR SHEET [ORGANOGENESIS, INC]2Legacy NDC, 1 package rows20120418_2dedbdf1-ba02-476c-94b5-80ee314d9c9f.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125400GintuitAllogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen351(a)Disc2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
42606-004-014260600040144.2 cm2 in 1 TRAY44.2 cm2Historical