What is NDC 66215-201?

66215-201 is the product NDC for Zavesca (miglustat), Miglustat 100 mg/1 capsule, listed with the FDA by Actelion Pharmaceuticals US, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Actelion Pharmaceuticals US, Inc., NDC labeler code 66215. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Zavesca?

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.

Zavesca NDC 66215-201 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)66215-201Labeler and product segments. Claims need a package NDC.

Product NDC at billing width66215-0201Add 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
66215-201-90	66215020190	6 BLISTER PACK in 1 CARTON (66215-201-90) / 15 CAPSULE in 1 BLISTER PACK (66215-201-15)Marketed from Jul 31, 2003

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Zavesca
Generic name (nonproprietary): miglustat
Active ingredients: Miglustat — 100 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Actelion Pharmaceuticals US, Inc.NDC labeler code 66215
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021348
Marketing start: Jul 31, 2003
Listing expires: Dec 31, 2026
Other FDA classes: Glucosylceramide Synthase Inhibitors (Mechanism)
Identifiers: Product ID 66215-201_f9cb16ee-d325-b331-e053-6394a90ab08cSPL ID f9cb16ee-d325-b331-e053-6394a90ab08cSPL set ID 817892d1-ee12-4632-85fc-57ccdf16d7b8RxCUI 401938, 541070UNII ADN3S497AZ
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

N466215020190 followed by a unit qualifier and the quantity

Package 66215-0201-90. 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 Apr 20, 2023.

Indications (excerpt from the label)

ZAVESCA is a glucosylceramide synthase inhibitor indicated as monotherapy for treatment of adult patients with mild/moderate type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option ( 1.1 ). 1.1 Type 1 Gaucher Disease ZAVESCA is indicated as monotherapy for the treatment of adult patients with mild to moderate type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option (e.g. due to allergy, hypersensitivity, or poor venous access).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 66215-201

What is NDC 66215-201?: 66215-201 is the product NDC for Zavesca (miglustat), Miglustat 100 mg/1 capsule, listed with the FDA by Actelion Pharmaceuticals US, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Zavesca (Miglustat).
What is the active ingredient?: Miglustat.
Who is the labeler?: Actelion Pharmaceuticals US, Inc., NDC labeler code 66215. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Zavesca?: 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 NDA 021348

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021348
Product	Strength	Form · route	Labeler	Product NDC
Miglustat	Miglustat 100 mg/1	CapsuleOral	CoTherix, Inc.	10148-201

Zavesca (Miglustat) NDC 66215-201