Prescription drug · ANDA

prucalopride NDC 72578-222

Prucalopride succinate 2 mg/1 · Tablet, Film coated · Oral · Viona Pharmaceuticals Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)72578-222Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72578-0222Add 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
72578-222-067257802220630 TABLET, FILM COATED in 1 BOTTLE (72578-222-06)Marketed from Feb 2, 2026

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)
prucalopride
Generic name (nonproprietary)
prucalopride
Active ingredients
Prucalopride succinate — 2 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 218056
Marketing start
Listing expires
Other FDA classes
Serotonin 4 Receptor Agonists (Mechanism)
Identifiers
Product ID 72578-222_6d8aeb40-9dce-4be0-897e-87ad2c5d828eSPL ID 6d8aeb40-9dce-4be0-897e-87ad2c5d828eSPL set ID af559917-802b-486c-9f7b-b770115acac8RxCUI 2107345, 2107353UNII 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

N472578022206 followed by a unit qualifier and the quantity

Package 72578-0222-06. 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)

Prucalopride tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults. Prucalopride tablet 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 ANDA 218056

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

FDA NDC Directory listings under ANDA 218056
ProductStrengthForm · routeLabelerProduct NDC
prucalopridePrucalopride succinate 2 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-1900
prucalopridePrucalopride succinate 1 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-1899
prucalopridePrucalopride succinate 1 mg/1Tablet, Film coatedOralViona Pharmaceuticals Inc72578-221

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prucalopride NDC 72578-222 | Med-Code