FDA.reportPublic FDA data

CARTICEL

Product NDC
69866-1025
11-digit product format
698661025
Labeler code
69866
Product ID
69866-1025_45501f23-533e-4c7a-9203-2974d40c8a26
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
autologous cultured chondrocytes
Dosage form
IMPLANT
Route
INTRA-ARTICULAR
Labeler
Vericel Corporation
Application
BLA103661
Marketing category
BLA
Marketing start
1905-06-19
Marketing end
0000-00-00
Substance
AUTOLOGOUS CULTURED CHONDROCYTES
Active strength
12000000 1/1
Pharmacologic classes
Autologous Cultured Cell [EPC],Cells, Cultured, Autologous [EXT],Chondrocytes [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69866-1025-12020-01-31C16284748780-19d75b9d0-c7c3-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Carticel ® safely and effectively. See full prescribing information for Carticel. Carticel (autologous cultured chondrocytes) For Autologous Implantation Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69866-1025-1CARTICEL1 in 1 VIAL, GLASSIMPLANT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69866-1025-1EA - Each69866-1025b7c1c8c1-7511-4699-a313-c4ed38e2822612017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69866-1025CARTICEL (AUTOLOGOUS CULTURED CHONDROCYTES) IMPLANT [VERICEL CORPORATION]2Legacy NDC, 1 package rows20170207_096cf052-6510-412a-abf3-24e5a33ea316.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69866-1025-1698661025011 in 1 VIAL, GLASSHistorical