Prescription drug · ANDA
Miglustat NDC 70710-2039
Miglustat 100 mg/1 · Capsule · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-2039-8 | 70710203908 | 6 BLISTER PACK in 1 CARTON (70710-2039-8) / 15 CAPSULE in 1 BLISTER PACK (70710-2039-4)Marketed from Apr 1, 2025 |
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)
- Miglustat
- Generic name (nonproprietary)
- miglustat
- Active ingredients
- Miglustat — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Zydus Pharmaceuticals USA Inc.NDC labeler code 70710
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219111
- Marketing start
- Listing expires
- Other FDA classes
- Enzyme Stabilizers (Mechanism)Glucosylceramide Synthase Inhibitors (Mechanism)
- Identifiers
- Product ID 70710-2039_3b0d8e2b-b3c4-4a26-a126-420f56734843SPL ID 3b0d8e2b-b3c4-4a26-a126-420f56734843SPL set ID b54cc8a0-2284-44c3-a8fa-d8aaa87a67c6RxCUI 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
N470710203908followed by a unit qualifier and the quantityPackage 70710-2039-08. 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)
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.
About NDC 70710-2039
- What is NDC 70710-2039?
- 70710-2039 is the product NDC for Miglustat, Miglustat 100 mg/1 capsule, listed with the FDA by Zydus Pharmaceuticals USA 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?
- Zydus Pharmaceuticals USA Inc., NDC labeler code 70710. 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.
Related NDCs: other Miglustat products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 | 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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Miglustat | Miglustat 100 mg/1 | CapsuleOral | Navinta LLC | 68475-204 |