FDA.reportPublic FDA data

MACI

Product NDC
69866-1030
Requested package NDC
69866-1030-8
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
MACI
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AUTOLOGOUS CULTURED CHONDROCYTES15000000 1/1
PORK COLLAGEN15 cm2/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
D5P3K3V822Internal UNII lookup
I8442U2G7JInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0c336c02-8c4c-4aa8-a992-9d2890a2539cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69866-1030-3MACI1 in 1 BOTTLE, PLASTICIMPLANT122
69866-1030-4MACI1 in 1 BAGIMPLANT122
69866-1030-5MACI1 in 1 BOXIMPLANT122
69866-1030-6MACI1 in 1 BOTTLE, PLASTICIMPLANT122
69866-1030-7MACI1 in 1 BAGIMPLANT122
69866-1030-8MACI2 in 1 BOXIMPLANT222

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69866-1030-1EA - Each69866-103090b65b5d-7f94-40f7-94bd-a9543960b5f912017-03-06
69866-1030-2EA - Each69866-103034564f7e-e6f7-4d9f-bcae-bfa23a28a9a712017-08-11
69866-1030-5EA - Each69866-103075ebc1e6-3f28-473e-b8f2-9624af2700a512021-07-15
69866-1030-8EA - Each69866-1030f0f9fce1-17c4-4cee-b9ce-b38f51d0c75b12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69866-1030MACI (AUTOLOGOUS CULTURED CHONDROCYTES) IMPLANT [VERICEL CORPORATION]20Current NDC, Legacy NDC, 6 package rows20240921_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MACIAUTOLOGOUS CULTURED CHONDROCYTESVericel Corporation0c336c02-8c4c-4aa8-a992-9d2890a2539c2026-03-09Warnings, Adverse reactionsExact identifier
application number: BLA125603
ndc (package): 69866-1030-8
ndc (product): 69866-1030
ndc11 (package): 69866103008

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125603Maciautologous cultured chondrocytes on porcine collagen membrane351(a)Rx2026-09-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69866-1030-8698661030082 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 bag2017-06-090000-00-00NoNoCurrent