Paliperidone
- Product NDC
- 67046-1539
- 11-digit product format
- 670461539
- Labeler code
- 67046
- Product ID
- 67046-1539_31352593-a65e-3b4e-e063-6294a90a49f9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paliperidone
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA204707
- Marketing category
- ANDA
- Marketing start
- 2025-03-25
- Substance
- PALIPERIDONE
- Active strength
- 3 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 838F01T721 | PALIPERIDONE | 144598-75-4 | PALIPERIDONE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 67046-1539-3 | 67046153903 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1539-3) | 2025-03-25 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Paliperidone | Coupler LLC | 2025-03-25 | HUMAN PRESCRIPTION DRUG LABEL | 1 |