NDC 69866-1030

MACI

Autologous Cultured Chondrocytes

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 ID: 69866-1030_3e5cd9de-7f86-4b99-b4b7-81c865ef846c
• NDC: 69866-1030
• Product Type: Cellular Therapy
• Proprietary Name: MACI
• Generic Name: Autologous Cultured Chondrocytes
• Dosage Form: Implant
• Route of Administration: INTRA-ARTICULAR
• Marketing Start Date: 2017-01-11
• Marketing Category: BLA / BLA
• Application Number: BLA125603
• Labeler Name: Vericel Corporation
• Substance Name: AUTOLOGOUS CULTURED CHONDROCYTES; PORK COLLAGEN
• Active Ingredient Strength: 15000000 1/1; cm2/1
• Pharm Classes: Autologous Cultured Cell [EPC],Cells, Cultured, Autologous [EXT],Chondrocytes [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69866-1030-1

1 POUCH in 1 BOX (69866-1030-1) > 1 CONTAINER in 1 POUCH > 1 IMPLANT in 1 CONTAINER

• Marketing Start Date: 2017-01-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69866-1030-2 [69866103002]

MACI IMPLANT

• Marketing Category: BLA
• Application Number: BLA125603
• Product Type: CELLULAR THERAPY
• Billing Unit: EA
• Marketing Start Date: 2017-06-27

NDC 69866-1030-1 [69866103001]

MACI IMPLANT

• Marketing Category: BLA
• Application Number: BLA125603
• Product Type: CELLULAR THERAPY
• Billing Unit: EA
• Marketing Start Date: 2017-01-11

Drug Details

Active Ingredients

Ingredient	Strength
AUTOLOGOUS CULTURED CHONDROCYTES	15000000 1/1

Pharmacological Class

• Autologous Cultured Cell [EPC]
• Cells
• Cultured
• Autologous [EXT]
• Chondrocytes [CS]

NDC Crossover Matching brand name "MACI" or generic name "Autologous Cultured Chondrocytes"

NDC	Brand Name	Generic Name
69866-1030	MACI	autologous cultured chondrocytes
69866-1025	CARTICEL	autologous cultured chondrocytes