PRUCALOPRIDE
- Product NDC
- 46708-077
- Requested package NDC
- 46708-077-30
- 11-digit product format
- 467080077
- Labeler code
- 46708
- Product ID
- 46708-077_89a7bdb1-e1cd-4986-bab9-a939dc764faa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PRUCALOPRIDE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA219234
- Marketing category
- ANDA
- Marketing start
- 2026-07-31
- Substance
- PRUCALOPRIDE SUCCINATE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Serotonin 4 Receptor Agonists [MoA]; Serotonin-4 Receptor Agonist [EPC]
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Source provenance: Browse the complete Orange Book source catalog.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PRUCALOPRIDE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PRUCALOPRIDE SUCCINATE | 1 mg/1 |
Harmonized UNII identifiers#
UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table| Identifier | FDA.report destination |
|---|
| 4V2G75E1CK | Internal UNII lookup |
Harmonized SPL set identifiers#
SPL set identifiers page 1 of 1 · 1 matching rows.
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Status |
|---|
| 46708-077-30 | 46708007730 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-077-30) | 2026-07-31 | 0 | Current |