What is NDC 58468-0160?

58468-0160 is the product NDC for Lumizyme (alglucosidase alfa), Alglucosidase alfa 5 mg/mL injection, powder, for solution, 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 Lumizyme?

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.

Lumizyme NDC 58468-0160 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)58468-0160Labeler and product segments. Claims need a package NDC.

Product NDC at billing width58468-0160Add 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
58468-0160-1	58468016001	1 VIAL, SINGLE-USE in 1 CARTON (58468-0160-1) / 10.5 mL in 1 VIAL, SINGLE-USEMarketed from May 24, 2010

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): Lumizyme
Generic name (nonproprietary): alglucosidase alfa
Active ingredients: Alglucosidase alfa — 5 mg/mL
Dosage form: Injection, Powder, For solution
Route: Intravenous
Labeler: Genzyme CorporationNDC labeler code 58468
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 125291
Marketing start: May 24, 2010
Listing expires: Dec 31, 2026
Other FDA classes: alpha-Glucosidases (Chemical structure)
Identifiers: Product ID 58468-0160_26b8bca9-7139-453b-afaa-2474ca711fc2SPL ID 26b8bca9-7139-453b-afaa-2474ca711fc2SPL set ID d6bfbc45-2d34-439e-8aad-59ee2d53d4dfRxCUI 629568, 993072UNII DTI67O9503
Pharmacologic class: Hydrolytic Lysosomal Glycogen-specific Enzyme

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

N458468016001 followed by a unit qualifier and the quantity

Package 58468-0160-01. 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 Jan 10, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

LUMIZYME ® is a hydrolytic lysosomal glycogen-specific enzyme indicated for patients with Pompe disease (acid α-glucosidase [GAA] deficiency). LUMIZYME ® is a hydrolytic lysosomal glycogen-specific enzyme indicated for patients with Pompe disease (GAA deficiency). ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 58468-0160

What is NDC 58468-0160?: 58468-0160 is the product NDC for Lumizyme (alglucosidase alfa), Alglucosidase alfa 5 mg/mL injection, powder, for solution, 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?: Lumizyme (Alglucosidase alfa).
What is the active ingredient?: Alglucosidase alfa.
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 Lumizyme?: 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.

Lumizyme (Alglucosidase alfa) NDC 58468-0160