Paliperidone
- Product NDC
- 69367-434
- 11-digit product format
- 693670434
- Labeler code
- 69367
- Product ID
- 69367-434_10e430a8-a911-4b08-8efb-694387c50531
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paliperidone
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Westminster Pharmaceuticals, LLC
- Application
- ANDA218755
- Marketing category
- ANDA
- Marketing start
- 2025-12-09
- Substance
- PALIPERIDONE
- Active strength
- 6 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Paliperidone
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PALIPERIDONE | 6 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 838F01T721 |
| Rxcui | 672567, 672569, 672571, 866103 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69367-434-30 | Paliperidone | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 2 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 672569 | paliperidone 6 MG 24HR Extended Release Oral Tablet | PSN | f75e884e-1883-45d7-ac9b-4a6c63f2185e | 100 |
| 672569 | 24 HR paliperidone 6 MG Extended Release Oral Tablet | SCD | f75e884e-1883-45d7-ac9b-4a6c63f2185e | 100 |
| 672569 | paliperidone 6 MG 24 HR Extended Release Oral Tablet | SY | f75e884e-1883-45d7-ac9b-4a6c63f2185e | 100 |
| 866103 | paliperidone 1.5 MG 24HR Extended Release Oral Tablet | PSN | 1745a460-5e3a-4a1f-8eb3-64bb112f47a4 | 2 |
| 672567 | paliperidone 3 MG 24HR Extended Release Oral Tablet | PSN | 1745a460-5e3a-4a1f-8eb3-64bb112f47a4 | 2 |
| 672569 | paliperidone 6 MG 24HR Extended Release Oral Tablet | PSN | 1745a460-5e3a-4a1f-8eb3-64bb112f47a4 | 2 |
| 672571 | paliperidone 9 MG 24HR Extended Release Oral Tablet | PSN | 1745a460-5e3a-4a1f-8eb3-64bb112f47a4 | 2 |
| 866103 | 24 HR paliperidone 1.5 MG Extended Release Oral Tablet | SCD | 1745a460-5e3a-4a1f-8eb3-64bb112f47a4 | 2 |
| 672567 | 24 HR paliperidone 3 MG Extended Release Oral Tablet | SCD | 1745a460-5e3a-4a1f-8eb3-64bb112f47a4 | 2 |
| 672569 | 24 HR paliperidone 6 MG Extended Release Oral Tablet | SCD | 1745a460-5e3a-4a1f-8eb3-64bb112f47a4 | 2 |
| 672571 | 24 HR paliperidone 9 MG Extended Release Oral Tablet | SCD | 1745a460-5e3a-4a1f-8eb3-64bb112f47a4 | 2 |
| 866103 | paliperidone 1.5 MG 24 HR Extended Release Oral Tablet | SY | 1745a460-5e3a-4a1f-8eb3-64bb112f47a4 | 2 |
| 672567 | paliperidone 3 MG 24 HR Extended Release Oral Tablet | SY | 1745a460-5e3a-4a1f-8eb3-64bb112f47a4 | 2 |
| 672569 | paliperidone 6 MG 24 HR Extended Release Oral Tablet | SY | 1745a460-5e3a-4a1f-8eb3-64bb112f47a4 | 2 |
| 672571 | paliperidone 9 MG 24 HR Extended Release Oral Tablet | SY | 1745a460-5e3a-4a1f-8eb3-64bb112f47a4 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 69367-434-30 | 69367043430 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69367-434-30) | 2025-12-09 | No | No | Current |