Cellular therapy · BLA
Maci (autologous cultured chondrocytes) NDC 69866-1030
Autologous cultured chondrocytes 15000000 1/1; Pork collagen 15 cm2/1 · Implant · Intra-articular · Vericel Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 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)Marketed from Jun 9, 2017 | |
| 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)Marketed from Jun 9, 2017 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Maci
- Generic name (nonproprietary)
- autologous cultured chondrocytes
- Active ingredients
- Autologous cultured chondrocytes — 15000000 1/1Pork collagen — 15 cm2/1
- Dosage form
- Implant
- Route
- Intra-articular
- Labeler
- Vericel Corporation
- Product type
- Cellular therapy
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125603
- Marketing start
- Listing expires
- Other FDA classes
- Autologous (EXT)Chondrocytes (Chemical structure)
- Identifiers
- Product ID 69866-1030_087aff67-ddb3-4562-8959-b37b5d05aec3SPL ID 087aff67-ddb3-4562-8959-b37b5d05aec3SPL set ID 0c336c02-8c4c-4aa8-a992-9d2890a2539cUNII D5P3K3V822, I8442U2G7J
- Pharmacologic class
- Autologous Cultured Cell
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N469866103005followed by a unit qualifier and the quantityPackage 69866-1030-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
MACI ® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the knee with or without bone involvement in adults. Limitations of Use Effectiveness of MACI in joints other than the knee has not been established. Safety and effectiveness of MACI in patients over the age of 55 years have not been established. MACI ® is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. ( 1 ) Limitations of Use Effectivene…
Excerpt only. Read the full label for complete information.