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
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42606-004-01 | GINTUIT | 44.2 cm2 in 1 TRAY | CELLULAR SHEET | 44.2 | | 2 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42606-004 | GINTUIT (ALLOGENEIC CULTURED KERATINOCYTES AND FIBROBLASTS IN BOVINE COLLAGEN) CELLULAR SHEET [ORGANOGENESIS, INC] | 2 | Legacy NDC, 1 package rows | 20120418_2dedbdf1-ba02-476c-94b5-80ee314d9c9f.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 42606-004-01 | 42606000401 | 44.2 cm2 in 1 TRAY | 44.2 cm2 | Historical |