Motegrity (prucalopride) NDC 54092-546

NDC codes

FDA NDC Directory

Product NDC (as listed)54092-546Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54092-0546Add 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
54092-546-01	54092054601	30 TABLET, FILM COATED in 1 BOTTLE (54092-546-01)Marketed from Dec 14, 2018

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): Motegrity
Generic name (nonproprietary): prucalopride
Active ingredients: Prucalopride succinate — 1 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Takeda Pharmaceuticals America, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 210166
Marketing start: Dec 14, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin 4 Receptor Agonists (Mechanism)
Identifiers: Product ID 54092-546_1278ace1-66f8-4bd8-8cf0-bd731f936563SPL ID 1278ace1-66f8-4bd8-8cf0-bd731f936563SPL set ID bca1e4c6-4b2b-4876-8ab3-654629c4ff1bRxCUI 2107345, 2107351, 2107353, 2107355UNII 4V2G75E1CK
Pharmacologic class: Serotonin-4 Receptor Agonist

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

N454092054601 followed by a unit qualifier and the quantity

Package 54092-0546-01. 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 Jul 17, 2025.

Indications (excerpt from the label)

MOTEGRITY ® is indicated for the treatment of chronic idiopathic constipation (CIC) in adults. MOTEGRITY is a serotonin-4 (5-HT 4 ) receptor agonist indicated for the treatment of chronic idiopathic constipation (CIC) in adults. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 210166

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

FDA NDC Directory listings under NDA 210166
Product	Strength	Form · route	Labeler	Product NDC
Motegrityprucalopride	Prucalopride succinate 2 mg/1	Tablet, Film coatedOral	Takeda Pharmaceuticals America, Inc.	54092-547