Prucalopride NDC 70748-389

NDC codes

FDA NDC Directory

Product NDC (as listed)70748-389Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70748-0389Add 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
70748-389-01	70748038901	30 TABLET, FILM COATED in 1 BOTTLE (70748-389-01)Marketed from Jun 25, 2025

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: Lupin Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218847
Marketing start: Jun 25, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin 4 Receptor Agonists (Mechanism)
Identifiers: Product ID 70748-389_b9640796-d193-4aff-b1d3-9399b0607d5cSPL ID b9640796-d193-4aff-b1d3-9399b0607d5cSPL set ID 124e8e82-972d-4800-9d68-14db416959b5RxCUI 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

N470748038901 followed by a unit qualifier and the quantity

Package 70748-0389-01. 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 Jan 8, 2026.

Indications (excerpt from the label)

Prucalopride tablets are indicated for the treatment of chronic idiopathic constipation (CIC) in adults. Prucalopride tablets are a serotonin-4 (5-HT 4 ) receptor agonist indicated for the treatment of chronic idiopathic constipation (CIC) in adults.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 218847

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

FDA NDC Directory listings under ANDA 218847
Product	Strength	Form · route	Labeler	Product NDC
Prucalopride	Prucalopride succinate 2 mg/1	Tablet, Film coatedOral	Lupin Pharmaceuticals, Inc.	70748-390