Prescription drug · ANDA
Prucalopride NDC 60505-4807
Prucalopride succinate 2 mg/1 · Tablet, Film coated · Oral · Apotex Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-4807-3 | 60505480703 | 30 TABLET, FILM COATED in 1 BOTTLE (60505-4807-3)Marketed from Jun 24, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Labeler
- Apotex Corp.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218977
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 4 Receptor Agonists (Mechanism)
- Identifiers
- Product ID 60505-4807_06f30acf-a55e-9a8d-e4e2-46d3a7d66639SPL ID 06f30acf-a55e-9a8d-e4e2-46d3a7d66639SPL set ID 01dcea95-b391-79da-bbfe-412f39022e9aRxCUI 2107345, 2107353UNII 4V2G75E1CKUPC 0360505480630, 0360505480739
- 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
N460505480703followed by a unit qualifier and the quantityPackage 60505-4807-03. 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 tablets are 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.
Other NDCs under ANDA 218977
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Prucalopride | Prucalopride succinate 1 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-038 |
| Prucalopride | Prucalopride succinate 2 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-039 |
| Prucalopride | Prucalopride succinate 1 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-4806 |