What is NDC 71904-300?

71904-300 is the product NDC for Opfolda (miglustat), Miglustat 65 mg/1 capsule, listed with the FDA by AMICUS THERAPEUTICS US, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

AMICUS THERAPEUTICS US, LLC, NDC labeler code 71904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Opfolda?

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.

Opfolda NDC 71904-300 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71904-300Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71904-0300Add 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
71904-300-01	71904030001	4 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-01) / 1 CAPSULE in 1 BOTTLE, PLASTICMarketed from Oct 11, 2023
71904-300-02	71904030002	24 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-02) / 1 CAPSULE in 1 BOTTLE, PLASTICMarketed from Oct 11, 2023
71904-300-03	71904030003	100 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-03) / 1 CAPSULE in 1 BOTTLE, PLASTICMarketed from Oct 11, 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): Opfolda
Generic name (nonproprietary): miglustat
Active ingredients: Miglustat — 65 mg/1
Dosage form: Capsule
Route: Oral
Labeler: AMICUS THERAPEUTICS US, LLCNDC labeler code 71904
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 215211
Marketing start: Oct 11, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Enzyme Stabilizers (Mechanism)Glucosylceramide Synthase Inhibitors (Mechanism)
Identifiers: Product ID 71904-300_82a91fa0-6c38-452c-a5d0-2c2f7355f540SPL ID 82a91fa0-6c38-452c-a5d0-2c2f7355f540SPL set ID d7c38298-37db-5a80-e053-2995a90aee40RxCUI 2667426, 2667432UNII ADN3S497AZUPC 0371904300016, 0371904300023, 0371904300030
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

N471904030001 followed by a unit qualifier and the quantity

Package 71904-0300-01. 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 27, 2024.

Indications (excerpt from the label)

OPFOLDA is indicated, in combination with Pombiliti, for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency) weighing ≥40 kg and who are not improving on their current enzyme replacement therapy (ERT). OPFOLDA is an enzyme stabilizer indicated, in combination with Pombiliti, a hydrolytic lysosomal glycogen-specific enzyme, for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency) weighing ≥40 kg and who are not improving on their current enzyme replacement therapy (ERT). ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71904-300

What is NDC 71904-300?: 71904-300 is the product NDC for Opfolda (miglustat), Miglustat 65 mg/1 capsule, listed with the FDA by AMICUS THERAPEUTICS US, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Opfolda (Miglustat).
What is the active ingredient?: Miglustat.
Who is the labeler?: AMICUS THERAPEUTICS US, LLC, NDC labeler code 71904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Opfolda?: 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.

Opfolda (Miglustat) NDC 71904-300