What is NDC 72578-221?

72578-221 is the product NDC for prucalopride, Prucalopride succinate 1 mg/1 tablet, film coated, listed with the FDA by Viona Pharmaceuticals Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

Viona Pharmaceuticals Inc, NDC labeler code 72578. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for prucalopride?

33 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

prucalopride NDC 72578-221 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72578-221Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72578-0221Add 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
72578-221-06	7257802210672578022106	30 TABLET, FILM COATED in 1 BOTTLE (72578-221-06)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 — 1 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Viona Pharmaceuticals IncNDC labeler code 72578
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218056
Marketing start: Feb 2, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin 4 Receptor Agonists (Mechanism)
Identifiers: Product ID 72578-221_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

N472578022106 followed by a unit qualifier and the quantity

Package 72578-0221-06. 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 Nov 19, 2025.

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)

About NDC 72578-221

What is NDC 72578-221?: 72578-221 is the product NDC for prucalopride, Prucalopride succinate 1 mg/1 tablet, film coated, listed with the FDA by Viona Pharmaceuticals Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: prucalopride.
What is the active ingredient?: Prucalopride succinate.
Who is the labeler?: Viona Pharmaceuticals Inc, NDC labeler code 72578. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for prucalopride?: 33 other product NDCs are listed under this name. See all prucalopride 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 prucalopride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Prucalopride	Prucalopride succinate 1 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-077	46708-0077-30
Prucalopride	Prucalopride succinate 2 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-078	46708-0078-30
Prucalopride	Prucalopride succinate 1 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-077	62332-0077-30
Prucalopride	Prucalopride succinate 2 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-078	62332-0078-30
prucalopride	Prucalopride succinate 1 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1899	70771-1899-03
prucalopride	Prucalopride succinate 2 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1900	70771-1900-03
prucalopride	Prucalopride succinate 2 mg/1	Tablet, Film coatedOral	Viona Pharmaceuticals Inc	72578-222	72578-0222-06
Prucalopride	Prucalopride 1 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-294	27241-0294-30
Prucalopride	Prucalopride 2 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-295	27241-0295-30
Prucalopride	Prucalopride succinate 1 mg/1	Tablet, Film coatedOral	AvKARE	73190-038	73190-0038-30

All 34 prucalopride NDCs

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
Product	Strength	Form · route	Labeler	Product NDC
prucalopride	Prucalopride succinate 1 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1899
prucalopride	Prucalopride succinate 2 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1900
prucalopride	Prucalopride succinate 2 mg/1	Tablet, Film coatedOral	Viona Pharmaceuticals Inc	72578-222