What is NDC 68475-204?

68475-204 is the product NDC for Miglustat, Miglustat 100 mg/1 capsule, listed with the FDA by Navinta LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Navinta LLC, NDC labeler code 68475. 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 68475-204 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68475-204Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68475-0204Add 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
68475-204-02	68475020402	6 BLISTER PACK in 1 CARTON (68475-204-02) / 15 CAPSULE in 1 BLISTER PACK (68475-204-01)Marketed from May 7, 2025
68475-204-04	68475020404	4 BLISTER PACK in 1 CARTON (68475-204-04) / 21 CAPSULE in 1 BLISTER PACK (68475-204-03)Marketed from Dec 23, 2025

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: Navinta LLCNDC labeler code 68475
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219111
Marketing start: May 7, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Enzyme Stabilizers (Mechanism)Glucosylceramide Synthase Inhibitors (Mechanism)
Identifiers: Product ID 68475-204_94491d95-3cdd-45cd-b94c-a0d4982618ccSPL ID 94491d95-3cdd-45cd-b94c-a0d4982618ccSPL set ID aa9a3ab6-2376-4b52-9e54-15dc87f25260RxCUI 401938UNII ADN3S497AZ
Pharmacologic class: Enzyme Stabilizer; 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

N468475020402 followed by a unit qualifier and the quantity

Package 68475-0204-02. 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 Dec 31, 2025.

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 68475-204

What is NDC 68475-204?: 68475-204 is the product NDC for Miglustat, Miglustat 100 mg/1 capsule, listed with the FDA by Navinta LLC. It has 2 package NDCs, 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?: Navinta LLC, NDC labeler code 68475. 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	Zydus Pharmaceuticals USA Inc.	70710-2039	70710-2039-08
Miglustat	Miglustat 100 mg/1	CapsuleOral	CoTherix, Inc.	10148-201	10148-0201-90
Miglustat	Miglustat 100 mg/1	CapsuleOral	ANI Pharmaceuticals, Inc.	43975-310	43975-0310-83

Other NDCs under ANDA 219111

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

FDA NDC Directory listings under ANDA 219111
Product	Strength	Form · route	Labeler	Product NDC
Miglustat	Miglustat 100 mg/1	CapsuleOral	Zydus Pharmaceuticals USA Inc.	70710-2039