What is NDC 43975-310?

43975-310 is the product NDC for Miglustat, Miglustat 100 mg/1 capsule, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

ANI Pharmaceuticals, Inc., NDC labeler code 43975. 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 43975-310 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43975-310Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43975-0310Add 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
43975-310-83	43975031083	6 BLISTER PACK in 1 CARTON (43975-310-83) / 15 CAPSULE in 1 BLISTER PACK (43975-310-08)Marketed from Apr 17, 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: ANI Pharmaceuticals, Inc.NDC labeler code 43975
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208342
Marketing start: Apr 17, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Enzyme Stabilizers (Mechanism)Glucosylceramide Synthase Inhibitors (Mechanism)
Identifiers: Product ID 43975-310_589c114d-45f1-423a-8064-846060d968ceSPL ID 589c114d-45f1-423a-8064-846060d968ceSPL set ID d746749d-de15-4225-b806-59b0765d25aeRxCUI 401938UNII ADN3S497AZUPC 0343975310836
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

N443975031083 followed by a unit qualifier and the quantity

Package 43975-0310-83. 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 Nov 26, 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 43975-310

What is NDC 43975-310?: 43975-310 is the product NDC for Miglustat, Miglustat 100 mg/1 capsule, listed with the FDA by ANI Pharmaceuticals, 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?: ANI Pharmaceuticals, Inc., NDC labeler code 43975. 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	CoTherix, Inc.	10148-201	10148-0201-90