Prucalopride
- Product NDC
- 60505-4807
- 11-digit product format
- 605054807
- Labeler code
- 60505
- Product ID
- 60505-4807_06f30acf-a55e-9a8d-e4e2-46d3a7d66639
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prucalopride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA218977
- Marketing category
- ANDA
- Marketing start
- 2025-06-24
- Substance
- PRUCALOPRIDE SUCCINATE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Serotonin 4 Receptor Agonists [MoA], Serotonin-4 Receptor Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Prucalopride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PRUCALOPRIDE SUCCINATE | 2 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 4V2G75E1CK |
| Rxcui | 2107345, 2107353 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c75476a7-e531-4d47-9c48-19159bd43a92 | Product name | 2 | 20251024 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60505-4807-3 | Prucalopride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60505-4807-3 | EA - Each | 60505-4807 | 5d5df8b4-6a1b-49f8-8af1-41373c7dbb26 | 1 | 2025-07-08 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2107345 | prucalopride 1 MG Oral Tablet | PSN | 01dcea95-b391-79da-bbfe-412f39022e9a | 3 |
| 2107353 | prucalopride 2 MG Oral Tablet | PSN | 01dcea95-b391-79da-bbfe-412f39022e9a | 3 |
| 2107345 | prucalopride 1 MG Oral Tablet | SCD | 01dcea95-b391-79da-bbfe-412f39022e9a | 3 |
| 2107353 | prucalopride 2 MG Oral Tablet | SCD | 01dcea95-b391-79da-bbfe-412f39022e9a | 3 |
| 2107345 | prucalopride 1 MG (equivalent to prucalopride succinate 1.32 MG) Oral Tablet | SY | 01dcea95-b391-79da-bbfe-412f39022e9a | 3 |
| 2107353 | prucalopride 2 MG (equivalent to prucalopride succinate 2.64 MG) Oral Tablet | SY | 01dcea95-b391-79da-bbfe-412f39022e9a | 3 |
| 2107345 | prucalopride 1 MG Oral Tablet | PSN | 3ac293af-5ce2-33f1-e063-6394a90aa01f | 1 |
| 2107353 | prucalopride 2 MG Oral Tablet | PSN | 3ac293af-5ce2-33f1-e063-6394a90aa01f | 1 |
| 2107345 | prucalopride 1 MG Oral Tablet | SCD | 3ac293af-5ce2-33f1-e063-6394a90aa01f | 1 |
| 2107353 | prucalopride 2 MG Oral Tablet | SCD | 3ac293af-5ce2-33f1-e063-6394a90aa01f | 1 |
| 2107345 | prucalopride 1 MG (equivalent to prucalopride succinate 1.32 MG) Oral Tablet | SY | 3ac293af-5ce2-33f1-e063-6394a90aa01f | 1 |
| 2107353 | prucalopride 2 MG (equivalent to prucalopride succinate 2.64 MG) Oral Tablet | SY | 3ac293af-5ce2-33f1-e063-6394a90aa01f | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 60505-4807-3 | 60505480703 | 30 TABLET, FILM COATED in 1 BOTTLE (60505-4807-3) | 2025-06-24 | No | No | Historical |