Prescription drug · NDA
Cerdelga (eliglustat) NDC 58468-0220
Eliglustat 84 mg/1 · Capsule · Oral · Genzyme Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58468-0220-1 | 58468022001 | 4 BLISTER PACK in 1 CARTON (58468-0220-1) / 14 CAPSULE in 1 BLISTER PACKMarketed from Sep 3, 2014 | |
| 58468-0220-2 | 58468022002 | 1 BLISTER PACK in 1 CARTON (58468-0220-2) / 14 CAPSULE in 1 BLISTER PACKMarketed from Sep 3, 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)
- Cerdelga
- Generic name (nonproprietary)
- eliglustat
- Active ingredients
- Eliglustat — 84 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Genzyme Corporation
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205494
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Glucosylceramide Synthase Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 58468-0220_e71b0b39-5a29-4e38-8500-55b6d1f48543SPL ID e71b0b39-5a29-4e38-8500-55b6d1f48543SPL set ID 819f828a-b888-4e46-83fc-94d774a28a83RxCUI 1547225, 1547231UNII DR40J4WA67
- Pharmacologic class
- Glucosylceramide Synthase Inhibitor
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N458468022001followed by a unit qualifier and the quantityPackage 58468-0220-01. 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 .
Indications (excerpt from the label)
CERDELGA is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1) who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test [see Dosage and Administration (2.1) ] . CERDELGA is a glucosylceramide synthase inhibitor indicated for the long-term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test. ( 1 ) Limitations of Use : CYP2D6 ultra-rapid metabolizers may not achieve adequate concentrations of CERDELGA to achieve a therapeutic effect…
Excerpt only. Read the full label for complete information.