What is NDC 83222-0200?

83222-0200 is the product NDC for Lenmeldy (atidarsagene autotemcel), Atidarsagene autotemcel 11800000 1/1 suspension, listed with the FDA by Orchard Therapeutics (Europe) Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Lenmeldy (Atidarsagene autotemcel).

Orchard Therapeutics (Europe) Ltd, NDC labeler code 83222. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Lenmeldy?

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.

Lenmeldy NDC 83222-0200 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)83222-0200Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83222-0200Add 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 NDC	11-digit (billing)	Package	Copy
83222-0200-1	83222020001	1 SUSPENSION in 1 BAG (83222-0200-1)Marketed from Apr 26, 2024

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): Lenmeldy
Generic name (nonproprietary): atidarsagene autotemcel
Active ingredients: Atidarsagene autotemcel — 11800000 1/1
Dosage form: Suspension
Route: Intravenous
Labeler: Orchard Therapeutics (Europe) LtdNDC labeler code 83222
Product type: Cellular therapy
Marketing category: BLA — Biologics License ApplicationApplication BLA 125758
Marketing start: Apr 26, 2024
Listing expires: Dec 31, 2027
Identifiers: Product ID 83222-0200_5474a8af-7dd9-3e6a-e063-6294a90a8de2SPL ID 5474a8af-7dd9-3e6a-e063-6294a90a8de2SPL set ID b3e307a7-561b-43b6-a784-9cb1dcfc5196RxCUI 2677920, 2677926UNII EPP8G99QG4

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.

How CPT relates to drug billing

NDC on a medical claim

N483222020001 followed by a unit qualifier and the quantity

Package 83222-0200-01. 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 Jun 17, 2026.

Indications (excerpt from the label)

LENMELDY is indicated for the treatment of children with pre-symptomatic late infantile (PSLI), pre-symptomatic early juvenile (PSEJ) or early symptomatic early juvenile (ESEJ) metachromatic leukodystrophy (MLD). LENMELDY is an autologous hematopoietic stem cell-based gene therapyindicated for the treatment of children with pre-symptomatic late infantile (PSLI), pre-symptomatic early juvenile (PSEJ) or early symptomatic early juvenile (ESEJ) metachromatic leukodystrophy (MLD).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 83222-0200

What is NDC 83222-0200?: 83222-0200 is the product NDC for Lenmeldy (atidarsagene autotemcel), Atidarsagene autotemcel 11800000 1/1 suspension, listed with the FDA by Orchard Therapeutics (Europe) Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Lenmeldy (Atidarsagene autotemcel).
What is the active ingredient?: Atidarsagene autotemcel.
Who is the labeler?: Orchard Therapeutics (Europe) Ltd, NDC labeler code 83222. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Lenmeldy?: 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.

Lenmeldy (Atidarsagene autotemcel) NDC 83222-0200