Prescription drug · ANDA
Yargesa (Miglustat) NDC 42799-709
Miglustat 100 mg/1 · Capsule · Oral · Edenbridge Pharmaceuticals LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42799-709-15 | 42799070915 | 1 BLISTER PACK in 1 CARTON (42799-709-15) / 15 CAPSULE in 1 BLISTER PACKMarketed from Oct 31, 2023 |
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)
- Yargesa
- Generic name (nonproprietary)
- miglustat
- Active ingredients
- Miglustat — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Edenbridge Pharmaceuticals LLC.NDC labeler code 42799
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209821
- Marketing start
- Listing expires
- Other FDA classes
- Enzyme Stabilizers (Mechanism)Glucosylceramide Synthase Inhibitors (Mechanism)
- Identifiers
- Product ID 42799-709_462f6c9d-b8f1-3a76-e063-6294a90a2b50SPL ID 462f6c9d-b8f1-3a76-e063-6294a90a2b50SPL set ID 2b371dfe-e2b0-47fe-b677-a7bde7149f87RxCUI 401938, 2642350UNII 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
N442799070915followed by a unit qualifier and the quantityPackage 42799-0709-15. 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)
YARGESA 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 YARGESA 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 42799-709
- What is NDC 42799-709?
- 42799-709 is the product NDC for Yargesa (miglustat), Miglustat 100 mg/1 capsule, listed with the FDA by Edenbridge Pharmaceuticals LLC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Yargesa (Miglustat).
- What is the active ingredient?
- Miglustat.
- Who is the labeler?
- Edenbridge Pharmaceuticals LLC., NDC labeler code 42799. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Yargesa?
- 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.