Prescription drug · ANDA
Prucalopride succinate NDC 70069-821
Prucalopride succinate 1 mg/1 · Tablet · Oral · Somerset Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70069-821-01 | 70069082101 | 1 BOTTLE in 1 BOTTLE (70069-821-01) / 30 TABLET in 1 BOTTLEMarketed from Jun 24, 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 succinate
- Generic name (nonproprietary)
- prucalopride succinate
- Active ingredients
- Prucalopride succinate — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Somerset Therapeutics, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219078
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 4 Receptor Agonists (Mechanism)
- Identifiers
- Product ID 70069-821_7b3acc62-d656-47b8-91d2-5b30cd699fbdSPL ID 7b3acc62-d656-47b8-91d2-5b30cd699fbdSPL set ID 1750cd94-b443-49df-9c53-eb5b68f66092RxCUI 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
N470069082101followed by a unit qualifier and the quantityPackage 70069-0821-01. 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 .
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 219078
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 succinate | Prucalopride succinate 2 mg/1 | TabletOral | Somerset Therapeutics, LLC | 70069-822 |