Prucalopride
- Product NDC
- 27241-294
- 11-digit product format
- 272410294
- Labeler code
- 27241
- Product ID
- 27241-294_ac2afe93-a78a-4dfe-8759-fec53f872e35
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prucalopride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Ajanta Pharma USA Inc.
- Application
- ANDA219220
- Marketing category
- ANDA
- Marketing start
- 2026-01-16
- Substance
- PRUCALOPRIDE
- Active strength
- 1 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 | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0A09IUW5TP |
| Rxcui | 2107345, 2107353 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 27241-294-30 | Prucalopride | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 27241-294-30 | 27241029430 | 30 TABLET in 1 BOTTLE (27241-294-30) | 30 tablet | 2026-01-16 | No | No | Historical |