PALIPERIDONE
- Product NDC
- 72658-1254
- 11-digit product format
- 726581254
- Labeler code
- 72658
- Product ID
- 72658-1254_3e4a14d9-8d90-5f05-e063-6294a90a110e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PALIPERIDONE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Eskayef Pharmaceuticals Limited
- Application
- ANDA218755
- Marketing category
- ANDA
- Marketing start
- 2025-10-02
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PALIPERIDONE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PALIPERIDONE | 3 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 838F01T721 |
| Rxcui | 672567, 672569, 672571, 866103 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3752075e-d817-45ea-9aa1-8dc0301cf2aa | Product name | 1 | 20251114 |
| 893dce58-6330-4a9a-ab03-5ffd7148e184 | Product name | 1 | 20250311 |
| b6847380-b533-d626-e29e-10b60b2ad451 | Product name | 9 | 20250303 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| fd328049-536a-4914-b42e-93bf4d93db24 | Product name | 1 | 20220307 |
| 0f0756fc-4d63-4f75-afcc-9c5e62a38d69 | Product name | 2 | 20220304 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72658-1254-1 | PALIPERIDONE | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 1 | |
| 72658-1254-2 | PALIPERIDONE | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | 1 | |
| 72658-1254-3 | PALIPERIDONE | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 866103 | paliperidone 1.5 MG 24HR Extended Release Oral Tablet | PSN | de95e29f-a030-4777-a601-874500ab8e91 | 1 |
| 672567 | paliperidone 3 MG 24HR Extended Release Oral Tablet | PSN | de95e29f-a030-4777-a601-874500ab8e91 | 1 |
| 672569 | paliperidone 6 MG 24HR Extended Release Oral Tablet | PSN | de95e29f-a030-4777-a601-874500ab8e91 | 1 |
| 672571 | paliperidone 9 MG 24HR Extended Release Oral Tablet | PSN | de95e29f-a030-4777-a601-874500ab8e91 | 1 |
| 866103 | 24 HR paliperidone 1.5 MG Extended Release Oral Tablet | SCD | de95e29f-a030-4777-a601-874500ab8e91 | 1 |
| 672567 | 24 HR paliperidone 3 MG Extended Release Oral Tablet | SCD | de95e29f-a030-4777-a601-874500ab8e91 | 1 |
| 672569 | 24 HR paliperidone 6 MG Extended Release Oral Tablet | SCD | de95e29f-a030-4777-a601-874500ab8e91 | 1 |
| 672571 | 24 HR paliperidone 9 MG Extended Release Oral Tablet | SCD | de95e29f-a030-4777-a601-874500ab8e91 | 1 |
| 866103 | paliperidone 1.5 MG 24 HR Extended Release Oral Tablet | SY | de95e29f-a030-4777-a601-874500ab8e91 | 1 |
| 672567 | paliperidone 3 MG 24 HR Extended Release Oral Tablet | SY | de95e29f-a030-4777-a601-874500ab8e91 | 1 |
| 672569 | paliperidone 6 MG 24 HR Extended Release Oral Tablet | SY | de95e29f-a030-4777-a601-874500ab8e91 | 1 |
| 672571 | paliperidone 9 MG 24 HR Extended Release Oral Tablet | SY | de95e29f-a030-4777-a601-874500ab8e91 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 72658-1254-1 | 72658125401 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72658-1254-1) | 2025-10-02 | No | No | Historical |
| 72658-1254-2 | 72658125402 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72658-1254-2) | 2025-10-02 | No | No | Historical |
| 72658-1254-3 | 72658125403 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72658-1254-3) | 2025-10-02 | No | No | Historical |