What is NDC 58468-0357?

58468-0357 is the product NDC for Campath (alemtuzumab), Alemtuzumab 30 mg/mL injection, listed with the FDA by Genzyme Corporation. It has 2 package NDCs, 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 Campath?

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.

Campath NDC 58468-0357 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)58468-0357Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58468-0357Add 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
58468-0357-1	58468035701	1 VIAL, SINGLE-USE in 1 CARTON (58468-0357-1) / 1 mL in 1 VIAL, SINGLE-USEMarketed from Nov 30, 2009
58468-0357-3	58468035703	3 VIAL, SINGLE-USE in 1 CARTON (58468-0357-3) / 1 mL in 1 VIAL, SINGLE-USEMarketed from Nov 30, 2009

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): Campath
Generic name (nonproprietary): alemtuzumab
Active ingredients: Alemtuzumab — 30 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: Genzyme CorporationNDC labeler code 58468
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 103948
Marketing start: Nov 30, 2009
Listing expires: Dec 31, 2026
Other FDA classes: CD52-directed Antibody Interactions (Mechanism)
Identifiers: Product ID 58468-0357_db03295a-9939-43bb-92c5-768721d27a8bSPL ID db03295a-9939-43bb-92c5-768721d27a8bSPL set ID 4f5f7255-7abc-4328-bd1a-ceaf139ef3e0RxCUI 828265, 828267UNII 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

N458468035701 followed by a unit qualifier and the quantity

Package 58468-0357-01. 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 5, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). CAMPATH is a CD52-directed cytolytic antibody indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58468-0357

What is NDC 58468-0357?: 58468-0357 is the product NDC for Campath (alemtuzumab), Alemtuzumab 30 mg/mL injection, listed with the FDA by Genzyme Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Campath (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 Campath?: 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
Lemtradaalemtuzumab	Alemtuzumab 12 mg/1.2mL	Injection, Solution, ConcentrateIntravenous	Genzyme Corporation	58468-0200

Campath (Alemtuzumab) NDC 58468-0357