NDC codes

FDA NDC Directory
Product NDC (as listed)70710-2039Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70710-2039Add 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
70710-2039-8707102039086 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

N470710203908 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Miglustat NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
MiglustatMiglustat 100 mg/1CapsuleOralNavinta LLC68475-20468475-0204-0268475-0204-04
MiglustatMiglustat 100 mg/1CapsuleOralCoTherix, Inc.10148-20110148-0201-90
MiglustatMiglustat 100 mg/1CapsuleOralANI Pharmaceuticals, Inc.43975-31043975-0310-83

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
ProductStrengthForm · routeLabelerProduct NDC
MiglustatMiglustat 100 mg/1CapsuleOralNavinta LLC68475-204

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