Prucalopride
- Product NDC
- 0054-0750
- 11-digit product format
- 000540750
- Labeler code
- 0054
- Product ID
- 0054-0750_e912e1b4-48aa-472d-b6c4-d1f769cff5e2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prucalopride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc
- Application
- ANDA217662
- 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 table| Ingredient | Strength |
|---|
| PRUCALOPRIDE SUCCINATE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4V2G75E1CK |
| Rxcui | 2107345, 2107353 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-0750-13 | Prucalopride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0054-0750-13 | 00054075013 | 30 TABLET, FILM COATED in 1 BOTTLE (0054-0750-13) | 2025-06-24 | No | No | Current |