What is NDC 10148-201?

10148-201 is the product NDC for Miglustat, Miglustat 100 mg/1 capsule, listed with the FDA by CoTherix, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

CoTherix, Inc., NDC labeler code 10148. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Miglustat?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Miglustat NDC 10148-201 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)10148-201Labeler and product segments. Claims need a package NDC.

Product NDC at billing width10148-0201Add 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
10148-201-90	10148020190	6 BLISTER PACK in 1 CARTON (10148-201-90) / 15 CAPSULE in 1 BLISTER PACK (10148-201-15)Marketed from Apr 25, 2018

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): Miglustat
Generic name (nonproprietary): miglustat
Active ingredients: Miglustat — 100 mg/1
Dosage form: Capsule
Route: Oral
Labeler: CoTherix, Inc.NDC labeler code 10148
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 021348
Marketing start: Apr 25, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Glucosylceramide Synthase Inhibitors (Mechanism)
Identifiers: Product ID 10148-201_fa2fce30-3172-6e10-e053-6294a90a1b5fSPL ID fa2fce30-3172-6e10-e053-6294a90a1b5fSPL set ID 76eb7ac8-e0ee-4409-a4e7-e326c6725836RxCUI 401938UNII 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

N410148020190 followed by a unit qualifier and the quantity

Package 10148-0201-90. 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 25, 2023.

Indications (excerpt from the label)

Miglustat 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 Miglustat 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 10148-201

What is NDC 10148-201?: 10148-201 is the product NDC for Miglustat, Miglustat 100 mg/1 capsule, listed with the FDA by CoTherix, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Miglustat.
What is the active ingredient?: Miglustat.
Who is the labeler?: CoTherix, Inc., NDC labeler code 10148. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Miglustat?: 3 other product NDCs are listed under this name. See all Miglustat NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Miglustat NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Miglustat	Miglustat 100 mg/1	CapsuleOral	Navinta LLC	68475-204	68475-0204-0268475-0204-04
Miglustat	Miglustat 100 mg/1	CapsuleOral	Zydus Pharmaceuticals USA Inc.	70710-2039	70710-2039-08
Miglustat	Miglustat 100 mg/1	CapsuleOral	ANI Pharmaceuticals, Inc.	43975-310	43975-0310-83

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
Zavescamiglustat	Miglustat 100 mg/1	CapsuleOral	Actelion Pharmaceuticals US, Inc.	66215-201