NDC codes

FDA NDC Directory
Product NDC (as listed)42799-709Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42799-0709Add 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 NDC11-digit (billing)PackageCopy
42799-709-15427990709151 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

N442799070915 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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