Prescription drug · ANDA
Prucalopride NDC 0781-8158
Prucalopride succinate 1 mg/1 · Tablet, Film coated · Oral · Sandoz Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-8158-31 | 00781815831 | 30 TABLET, FILM COATED in 1 BOTTLE (0781-8158-31)Marketed from Jun 13, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Sandoz Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218963
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 4 Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0781-8158_0145490a-4ba4-4b33-8602-4a6e9ca52ff2SPL ID 0145490a-4ba4-4b33-8602-4a6e9ca52ff2SPL set ID 6325308c-4b0f-4926-bb85-b63db614533dRxCUI 2107345, 2107353UNII 4V2G75E1CKUPC 0307818159310
- 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
N400781815831followed by a unit qualifier and the quantityPackage 00781-8158-31. 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 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 218963
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 2 mg/1 | Tablet, Film coatedOral | Sandoz Inc. | 0781-8159 |