PRUCALOPRIDE
- Product NDC
- 83085-005
- 11-digit product format
- 830850005
- Labeler code
- 83085
- Product ID
- 83085-005_25c68e03-9af5-47da-95ce-ca870a8b531f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PRUCALOPRIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- SKG Pharma Inc.
- Application
- ANDA218812
- Marketing category
- ANDA
- Marketing start
- 2025-06-24
- Substance
- PRUCALOPRIDE SUCCINATE
- Active strength
- 1 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 | 1 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 |
|---|
| 83085-005-30 | PRUCALOPRIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 83085-005-30 | 83085000530 | 30 TABLET, FILM COATED in 1 BOTTLE (83085-005-30) | 2025-06-24 | No | No | Current |