Prescription drug · BLA
Fabrazyme (Agalsidase beta) NDC 58468-0040
Agalsidase beta 5 mg/mL · Injection, Powder, Lyophilized, For solution · Intravenous · Genzyme Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58468-0040-1 | 58468004001 | 1 VIAL, GLASS in 1 CARTON (58468-0040-1) / 7 mL in 1 VIAL, GLASSMarketed from Dec 17, 2008 |
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)
- Fabrazyme
- Generic name (nonproprietary)
- agalsidase beta
- Active ingredients
- Agalsidase beta — 5 mg/mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Genzyme CorporationNDC labeler code 58468
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103979
- Marketing start
- Listing expires
- Other FDA classes
- alpha-Glucosidases (Chemical structure)
- Identifiers
- Product ID 58468-0040_9b786f81-f4d8-4bc6-8f5f-68adbbfb60d1SPL ID 9b786f81-f4d8-4bc6-8f5f-68adbbfb60d1SPL set ID 988513ab-b06f-4dd0-93f7-d2d4531dcce4RxCUI 1804755, 1804758, 1804760, 1804762UNII RZD65TSM9U
- Pharmacologic class
- Hydrolytic Lysosomal Neutral Glycosphingolipid-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.
- NDC on a medical claim
N458468004001followed by a unit qualifier and the quantityPackage 58468-0040-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
FABRAZYME ® is indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease. FABRAZYME is a hydrolytic lysosomal neutral glycosphingolipid-specific enzyme indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 58468-0040
- What is NDC 58468-0040?
- 58468-0040 is the product NDC for Fabrazyme (agalsidase beta), Agalsidase beta 5 mg/mL injection, powder, lyophilized, 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?
- Fabrazyme (Agalsidase beta).
- What is the active ingredient?
- Agalsidase beta.
- 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 Fabrazyme?
- 1 other product NDC are listed under this name. See all Fabrazyme NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fabrazyme products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fabrazymeagalsidase beta | Agalsidase beta 5 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Genzyme Corporation | 58468-0041 | 58468-0041-01 |
Other NDCs under BLA 103979
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Fabrazymeagalsidase beta | Agalsidase beta 5 mg/mL | Injection, Powder, Lyophilized, For solutionIntravenous | Genzyme Corporation | 58468-0041 |