Prucalopride
- Product NDC
- 70954-597
- 11-digit product format
- 709540597
- Labeler code
- 70954
- Product ID
- 70954-597_a33b876a-c96e-4f3d-a1b8-56c4daa46892
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prucalopride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA218492
- Marketing category
- ANDA
- Marketing start
- 2024-12-27
- 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 |
|---|
| 70954-597-10 | Prucalopride | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70954-597 | PRUCALOPRIDE TABLET [ANI PHARMACEUTICALS, INC.] | 1 | Current NDC, 1 package rows | 20241229_6d82dfbd-f171-4045-9f7a-268e189a658a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70954-597-10 | 70954059710 | 30 TABLET in 1 BOTTLE (70954-597-10) | 30 tablet | 2024-12-27 | No | No | Current |