Prescription drug · ANDA
Prucalopride NDC 0054-0750
Prucalopride succinate 2 mg/1 · Tablet, Film coated · Oral · Hikma Pharmaceuticals USA Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-0750-13 | 00054075013 | 30 TABLET, FILM COATED in 1 BOTTLE (0054-0750-13)Marketed from Jun 24, 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 — 2 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217662
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 4 Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0054-0750_465087cc-8848-48bf-8575-87c361d6b240SPL ID 465087cc-8848-48bf-8575-87c361d6b240SPL set ID e1e9e36c-ce5a-4323-9d20-395bb5e80e64RxCUI 2107345, 2107353UNII 4V2G75E1CKUPC 0300540749132, 0300540750138
- 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
N400054075013followed by a unit qualifier and the quantityPackage 00054-0750-13. 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 217662
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 | Hikma Pharmaceuticals USA Inc | 0054-0749 |