Home NDC 69866-1030 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 UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination D5P3K3V822 Internal UNII lookup I8442U2G7J Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MACI AUTOLOGOUS CULTURED CHONDROCYTES Vericel Corporation 0c336c02-8c4c-4aa8-a992-9d2890a2539c 2026-03-09 Warnings, Adverse reactions Exact identifier application number: BLA125603 ndc (product): 69866-1030
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125603 Maci autologous cultured chondrocytes on porcine collagen membrane 351(a) Rx 2026-06-01
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