Miplyffa (arimoclomol citrate) NDC 72542-193

NDC codes

FDA NDC Directory

Product NDC (as listed)72542-193Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72542-0193Add 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	Copy
72542-193-01	72542019301	1 BOTTLE in 1 CARTON (72542-193-01) / 90 CAPSULE in 1 BOTTLEMarketed from Sep 20, 2024

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): Miplyffa
Generic name (nonproprietary): arimoclomol citrate
Active ingredients: Arimoclomol citrate — 93 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Acer Therapeutics Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 214927
Marketing start: Sep 20, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Organic Cation Transporter 2 Inhibitors (Mechanism)
Identifiers: Product ID 72542-193_18850625-1a1d-4351-862e-5d46b08eb978SPL ID 18850625-1a1d-4351-862e-5d46b08eb978SPL set ID 5feffc0e-453d-47fa-91dd-38d4952309bcRxCUI 2694288, 2694294, 2694296, 2694298, 2694300, 2694302, 2694304, 2694306UNII Q85FFY6179UPC 0372542147018

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

N472542019301 followed by a unit qualifier and the quantity

Package 72542-0193-01. 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 Mar 18, 2026.

Indications (excerpt from the label)

MIPLYFFA is indicated for use in combination with miglustat for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adult and pediatric patients 2 years of age and older. MIPLYFFA is indicated for use in combination with miglustat for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adult and pediatric patients 2 years of age and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 214927

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 214927
Product	Strength	Form · route	Labeler	Product NDC
Miplyffaarimoclomol citrate	Arimoclomol citrate 124 mg/1	CapsuleOral	Acer Therapeutics Inc.	72542-124
Miplyffaarimoclomol citrate	Arimoclomol citrate 47 mg/1	CapsuleOral	Acer Therapeutics Inc.	72542-147
Miplyffaarimoclomol citrate	Arimoclomol citrate 62 mg/1	CapsuleOral	Acer Therapeutics Inc.	72542-162