Prucalopride
- Product NDC
- 70748-390
- 11-digit product format
- 707480390
- Labeler code
- 70748
- Product ID
- 70748-390_b9640796-d193-4aff-b1d3-9399b0607d5c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prucalopride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA218847
- Marketing category
- ANDA
- Marketing start
- 2025-06-25
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Prucalopride
- Listing expiration
- 2027-12-31
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 |
|---|
| 70748-390-01 | Prucalopride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 7 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70748-390-01 | 70748039001 | 30 TABLET, FILM COATED in 1 BOTTLE (70748-390-01) | 2025-06-25 | No | No | Current |