Cellular therapy · BLA
Lantidra (Donislecel) NDC 73539-001
Donislecel 5000 [arb'U]/400mL · Solution · Intravascular · CellTrans Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73539-001-01 | 73539000101 | 400 mL in 1 BAG (73539-001-01)Marketed from Jun 28, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Lantidra
- Generic name (nonproprietary)
- donislecel
- Active ingredients
- Donislecel — 5000 [arb'U]/400mL
- Dosage form
- Solution
- Route
- Intravascular
- Labeler
- CellTrans Inc.NDC labeler code 73539
- Product type
- Cellular therapy
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125734
- Marketing start
- Listing expires
- Identifiers
- Product ID 73539-001_a3163e14-0404-4e27-884b-f6f9f7f695bcSPL ID a3163e14-0404-4e27-884b-f6f9f7f695bcSPL set ID 24610d9f-0c5a-4f55-93b3-d456300bfd5dRxCUI 2642264, 2642270UNII FW00DG4E3P
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.
- NDC on a medical claim
N473539000101followed by a unit qualifier and the quantityPackage 73539-0001-01. 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)
LANTIDRA is an allogeneic pancreatic islet cellular therapy indicated for the treatment of adults with Type 1 diabetes who are unable to approach target HbA1c because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education. Use LANTIDRA in conjunction with concomitant immunosuppression. LANTIDRA is an allogeneic pancreatic islet cellular therapy indicated for the treatment of adults with Type 1 diabetes who are unable to approach target HbA1c because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education. Use in conjunction with concomitant immunosuppression. ( 1 ) Limitations of Use When conside…
Excerpt only. Read the full label for complete information.
About NDC 73539-001
- What is NDC 73539-001?
- 73539-001 is the product NDC for Lantidra (donislecel), Donislecel 5000 [arb'U]/400mL solution, listed with the FDA by CellTrans Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lantidra (Donislecel).
- What is the active ingredient?
- Donislecel.
- Who is the labeler?
- CellTrans Inc., NDC labeler code 73539. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lantidra?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.