Prescription drug · BLA
Cerezyme (imiglucerase) NDC 58468-4663
Imiglucerase 40 U/mL · Injection, Powder, Lyophilized, For solution · Intravenous · Genzyme Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58468-4663-1 | 58468466301 | 1 VIAL, GLASS in 1 CARTON (58468-4663-1) / 10 mL in 1 VIAL, GLASSMarketed from May 23, 1994 |
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)
- Cerezyme
- Generic name (nonproprietary)
- imiglucerase
- Active ingredients
- Imiglucerase — 40 U/mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Genzyme Corporation
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 020367
- Marketing start
- Listing expires
- Other FDA classes
- Glucosylceramidase (Chemical structure)
- Identifiers
- Product ID 58468-4663_fc9b5df4-94e5-43b1-a827-dff85f7cf510SPL ID fc9b5df4-94e5-43b1-a827-dff85f7cf510SPL set ID df60f030-866b-4374-a31f-8ae3f6b45c38RxCUI 1726266, 1726268UNII Q6U6J48BWY
- Pharmacologic class
- Hydrolytic Lysosomal Glucocerebroside-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
N458468466301followed by a unit qualifier and the quantityPackage 58468-4663-01. 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)
CEREZYME is indicated for the treatment of non-central nervous system (CNS) manifestations of Type 1 or Type 3 Gaucher disease in adults and pediatric patients. CEREZYME is a hydrolytic lysosomal glucocerebrosidase-specific enzyme indicated for the treatment of non-central nervous system (CNS) manifestations of Type 1 or Type 3 Gaucher disease in adults and pediatric patients. ( 1 )
Excerpt only. Read the full label for complete information.