Paliperidone
- Product NDC
- 67046-1630
- 11-digit product format
- 670461630
- Labeler code
- 67046
- Product ID
- 67046-1630_463dba10-7245-c1aa-e063-6394a90ad7b1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paliperidone
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA204707
- Marketing category
- ANDA
- Marketing start
- 2025-12-18
- Substance
- PALIPERIDONE
- Active strength
- 6 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Paliperidone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PALIPERIDONE | 6 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 838F01T721 |
| Rxcui | 672569 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67046-1630-3 | Paliperidone | 30 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 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 |
|---|
| 67046-1630-3 | 67046163003 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1630-3) | 2025-12-18 | No | No | Historical |