MACI
- Product NDC
- 69866-1030
- 11-digit product format
- 698661030
- Labeler code
- 69866
- Product ID
- 69866-1030_087aff67-ddb3-4562-8959-b37b5d05aec3
- Type
- CELLULAR THERAPY
- Nonproprietary name
- autologous cultured chondrocytes
- Dosage form
- IMPLANT
- Route
- INTRA-ARTICULAR
- Labeler
- Vericel Corporation
- Application
- BLA125603
- Marketing category
- BLA
- Marketing start
- 2017-06-09
- Substance
- AUTOLOGOUS CULTURED CHONDROCYTES; PORK COLLAGEN
- Active strength
- 15000000; 15 1/1; cm2/1
- Pharmacologic classes
- Autologous Cultured Cell [EPC], Cells, Cultured, Autologous [EXT], Chondrocytes [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MACI
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AUTOLOGOUS CULTURED CHONDROCYTES | 15000000 1/1 |
| PORK COLLAGEN | 15 cm2/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D5P3K3V822, I8442U2G7J |
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69866-1030 | MACI (AUTOLOGOUS CULTURED CHONDROCYTES) IMPLANT [VERICEL CORPORATION] | 20 | Current NDC, Legacy NDC, 6 package rows | 20240921_0c336c02-8c4c-4aa8-a992-9d2890a2539c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69866-1030-1 | 69866103001 | 1 POUCH in 1 BOX (69866-1030-1) > 1 CONTAINER in 1 POUCH > 1 IMPLANT in 1 CONTAINER | 1 pouch | 2017-01-11 | 0000-00-00 | No | No | Current |
| 69866-1030-2 | 69866103002 | 1 POUCH in 1 BOX (69866-1030-2) > 2 CONTAINER in 1 POUCH > 1 IMPLANT in 1 CONTAINER | 1 pouch | 2017-01-11 | 0000-00-00 | No | No | Current |
| 69866-1030-3 | 69866103003 | 1 in 1 BOTTLE, PLASTIC | | | | | | Historical |
| 69866-1030-4 | 69866103004 | 1 in 1 BAG | | | | | | Historical |
| 69866-1030-5 | 69866103005 | 1 BAG in 1 BOX (69866-1030-5) / 1 BOTTLE, PLASTIC in 1 BAG (69866-1030-4) / 1 IMPLANT in 1 BOTTLE, PLASTIC (69866-1030-3) | 1 bag | 2017-06-09 | 0000-00-00 | No | No | Current |
| 69866-1030-6 | 69866103006 | 1 in 1 BOTTLE, PLASTIC | | | | | | Historical |
| 69866-1030-7 | 69866103007 | 1 in 1 BAG | | | | | | Historical |
| 69866-1030-8 | 69866103008 | 2 BAG in 1 BOX (69866-1030-8) / 1 BOTTLE, PLASTIC in 1 BAG (69866-1030-7) / 1 IMPLANT in 1 BOTTLE, PLASTIC (69866-1030-6) | 2 bag | 2017-06-09 | 0000-00-00 | No | No | Current |