NDC 42606-004

GINTUIT

Allogeneic Cultured Keratinocytes And Fibroblasts In Bovine Collagen

GINTUIT is a Topical Cellular Sheet in the Cellular Therapy category. It is labeled and distributed by Organogenesis, Inc. The primary component is Foreskin Fibroblast (neonatal); Bovine Type I Collagen; Foreskin Keratinocyte (neonatal).

• Product ID: 42606-004_499fd880-257d-49d2-972f-68be99d6e5cd
• NDC: 42606-004
• Product Type: Cellular Therapy
• Proprietary Name: GINTUIT
• Generic Name: Allogeneic Cultured Keratinocytes And Fibroblasts In Bovine Collagen
• Dosage Form: Cellular Sheet
• Route of Administration: TOPICAL
• Marketing Start Date: 2012-03-15
• Marketing Category: BLA / BLA
• Application Number: BLA125400
• Labeler Name: Organogenesis, Inc
• Substance Name: FORESKIN FIBROBLAST (NEONATAL); BOVINE TYPE I COLLAGEN; FORESKIN KERATINOCYTE (NEONATAL)
• Active Ingredient Strength: 0 /; /; /
• Pharm 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

Packaging

NDC 42606-004-01

44.2 cm2 in 1 TRAY (42606-004-01)

• Marketing Start Date: 2012-03-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42606-004-01 [42606000401]

GINTUIT CELLULAR SHEET

• Marketing Category: BLA
• Application Number: BLA125400
• Product Type: CELLULAR THERAPY
• Marketing Start Date: 2012-03-15
• Inactivation Date: 2019-11-13

Drug Details

Active Ingredients

Ingredient	Strength
FORESKIN FIBROBLAST (NEONATAL)

Pharmacological Class

• 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]