Prescription drug · ANDA
Prucalopride NDC 70954-597
Prucalopride succinate 2 mg/1 · Tablet · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-597-10 | 70954059710 | 30 TABLET in 1 BOTTLE (70954-597-10)Marketed from Dec 27, 2024 |
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 — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218492
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 4 Receptor Agonists (Mechanism)
- Identifiers
- Product ID 70954-597_a33b876a-c96e-4f3d-a1b8-56c4daa46892SPL ID a33b876a-c96e-4f3d-a1b8-56c4daa46892SPL set ID 6d82dfbd-f171-4045-9f7a-268e189a658aRxCUI 2107345, 2107353UNII 4V2G75E1CKUPC 0370954597100, 0370954596103
- 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
N470954059710followed by a unit qualifier and the quantityPackage 70954-0597-10. 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 tablet is 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.
Other NDCs under ANDA 218492
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 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-596 |