NDC codes

FDA NDC Directory
Product NDC (as listed)73539-001Labeler and product segments. Claims need a package NDC.
Product NDC at billing width73539-0001Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
73539-001-0173539000101400 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

N473539000101 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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