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NDC 69866-1030-05 MACI 15000000; 15 1/1; cm2/1 Details
MACI 15000000; 15 1/1; cm2/1
MACI is a INTRA-ARTICULAR IMPLANT in the CELLULAR THERAPY category. It is labeled and distributed by Vericel Corporation. The primary component is AUTOLOGOUS CULTURED CHONDROCYTES; PORK COLLAGEN.
Product Information
| NDC | 69866-1030 |
|---|---|
| Product ID | 69866-1030_fde88bef-fa85-4f86-8c0c-e4ad5668e202 |
| Associated GPIs | 75840015209100 |
| GCN Sequence Number | 076989 |
| GCN Sequence Number Description | autol chrondrocy/collagen,porc SHEET 500K/CM2 IMPLANT |
| HIC3 | S1A |
| HIC3 Description | JOINT TISSUE REPLACEMENT |
| GCN | 42853 |
| HICL Sequence Number | 044023 |
| HICL Sequence Number Description | AUTOLOGOUS CULTURED CHONDROCYTES/COLLAGEN, PORCINE |
| Brand/Generic | Brand |
| Proprietary Name | MACI |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | autologous cultured chondrocytes |
| Product Type | CELLULAR THERAPY |
| Dosage Form | IMPLANT |
| Route | INTRA-ARTICULAR |
| Active Ingredient Strength | 15000000; 15 |
| Active Ingredient Units | 1/1; cm2/1 |
| Substance Name | AUTOLOGOUS CULTURED CHONDROCYTES; PORK COLLAGEN |
| Labeler Name | Vericel Corporation |
| Pharmaceutical Class | Autologous Cultured Cell [EPC], Cells, Cultured, Autologous [EXT], Chondrocytes [CS] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA125603 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69866-1030-05 (69866103005)
| NDC Package Code | 69866-1030-5 |
|---|---|
| Billing NDC | 69866103005 |
| Package | 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) |
| Marketing Start Date | 2017-06-09 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |