What is NDC 58468-0200?

58468-0200 is the product NDC for Lemtrada (alemtuzumab), Alemtuzumab 12 mg/1.2mL injection, solution, concentrate, listed with the FDA by Genzyme Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.

Genzyme Corporation, NDC labeler code 58468. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Lemtrada?

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.

Lemtrada NDC 58468-0200 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)58468-0200Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58468-0200Add 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
58468-0200-1	58468020001	1 VIAL, SINGLE-USE in 1 CARTON (58468-0200-1) / 1.2 mL in 1 VIAL, SINGLE-USEMarketed from Nov 18, 2014

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): Lemtrada
Generic name (nonproprietary): alemtuzumab
Active ingredients: Alemtuzumab — 12 mg/1.2mL
Dosage form: Injection, Solution, Concentrate
Route: Intravenous
Labeler: Genzyme CorporationNDC labeler code 58468
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 103948
Marketing start: Nov 18, 2014
Listing expires: Dec 31, 2026
Other FDA classes: CD52-directed Antibody Interactions (Mechanism)
Identifiers: Product ID 58468-0200_e9b870b2-1ea2-433f-991a-721c3cf582b1SPL ID e9b870b2-1ea2-433f-991a-721c3cf582b1SPL set ID 6236b0bc-82e9-4447-9a78-f57d94770269RxCUI 1594658, 1594663UNII 3A189DH42V
Pharmacologic class: CD52-directed Cytolytic Antibody

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

N458468020001 followed by a unit qualifier and the quantity

Package 58468-0200-01. 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 Nov 3, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

LEMTRADA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, the use of LEMTRADA should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS [see Warnings and Precautions (5) ] . LEMTRADA is a CD52-directed cytolytic monoclonal antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, the use of LEMTRADA should generally be res…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58468-0200

What is NDC 58468-0200?: 58468-0200 is the product NDC for Lemtrada (alemtuzumab), Alemtuzumab 12 mg/1.2mL injection, solution, concentrate, listed with the FDA by Genzyme Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Lemtrada (Alemtuzumab).
What is the active ingredient?: Alemtuzumab.
Who is the labeler?: Genzyme Corporation, NDC labeler code 58468. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Lemtrada?: 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.

Other NDCs under BLA 103948

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 103948
Product	Strength	Form · route	Labeler	Product NDC
Campathalemtuzumab	Alemtuzumab 30 mg/mL	InjectionIntravenous	Genzyme Corporation	58468-0357

Lemtrada (Alemtuzumab) NDC 58468-0200