Paliperidone
- Product NDC
- 65162-283
- 11-digit product format
- 651620283
- Labeler code
- 65162
- Product ID
- 65162-283_d01cb993-8ed1-4746-ad80-d95d3025c3ac
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paliperidone
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA204707
- Marketing category
- ANDA
- Marketing start
- 2019-09-24
- Substance
- PALIPERIDONE
- Active strength
- 9 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 | 9 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 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| fd328049-536a-4914-b42e-93bf4d93db24 | Product name | 1 | 20220307 |
| 0f0756fc-4d63-4f75-afcc-9c5e62a38d69 | Product name | 2 | 20220304 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65162-283-03 | Paliperidone | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 16 | |
| 65162-283-09 | Paliperidone | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65162-283-03 | EA - Each | 65162-283 | c12e1383-1089-4325-b61f-19934e23aae4 | 1 | 2019-11-12 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 866103 | paliperidone 1.5 MG 24HR Extended Release Oral Tablet | PSN | 7b269778-803b-4ce2-a8c0-636fb131d16a | 16 |
| 672567 | paliperidone 3 MG 24HR Extended Release Oral Tablet | PSN | 7b269778-803b-4ce2-a8c0-636fb131d16a | 16 |
| 672569 | paliperidone 6 MG 24HR Extended Release Oral Tablet | PSN | 7b269778-803b-4ce2-a8c0-636fb131d16a | 16 |
| 672571 | paliperidone 9 MG 24HR Extended Release Oral Tablet | PSN | 7b269778-803b-4ce2-a8c0-636fb131d16a | 16 |
| 866103 | 24 HR paliperidone 1.5 MG Extended Release Oral Tablet | SCD | 7b269778-803b-4ce2-a8c0-636fb131d16a | 16 |
| 672567 | 24 HR paliperidone 3 MG Extended Release Oral Tablet | SCD | 7b269778-803b-4ce2-a8c0-636fb131d16a | 16 |
| 672569 | 24 HR paliperidone 6 MG Extended Release Oral Tablet | SCD | 7b269778-803b-4ce2-a8c0-636fb131d16a | 16 |
| 672571 | 24 HR paliperidone 9 MG Extended Release Oral Tablet | SCD | 7b269778-803b-4ce2-a8c0-636fb131d16a | 16 |
| 866103 | paliperidone 1.5 MG 24 HR Extended Release Oral Tablet | SY | 7b269778-803b-4ce2-a8c0-636fb131d16a | 16 |
| 672567 | paliperidone 3 MG 24 HR Extended Release Oral Tablet | SY | 7b269778-803b-4ce2-a8c0-636fb131d16a | 16 |
| 672569 | paliperidone 6 MG 24 HR Extended Release Oral Tablet | SY | 7b269778-803b-4ce2-a8c0-636fb131d16a | 16 |
| 672571 | paliperidone 9 MG 24 HR Extended Release Oral Tablet | SY | 7b269778-803b-4ce2-a8c0-636fb131d16a | 16 |
| 866103 | paliperidone 1.5 MG 24HR Extended Release Oral Tablet | PSN | 018cf3ca-bee9-23a6-e063-6394a90ad905 | 3 |
| 672567 | paliperidone 3 MG 24HR Extended Release Oral Tablet | PSN | 018cf3ca-bee9-23a6-e063-6394a90ad905 | 3 |
| 672569 | paliperidone 6 MG 24HR Extended Release Oral Tablet | PSN | 018cf3ca-bee9-23a6-e063-6394a90ad905 | 3 |
| 672571 | paliperidone 9 MG 24HR Extended Release Oral Tablet | PSN | 018cf3ca-bee9-23a6-e063-6394a90ad905 | 3 |
| 866103 | 24 HR paliperidone 1.5 MG Extended Release Oral Tablet | SCD | 018cf3ca-bee9-23a6-e063-6394a90ad905 | 3 |
| 672567 | 24 HR paliperidone 3 MG Extended Release Oral Tablet | SCD | 018cf3ca-bee9-23a6-e063-6394a90ad905 | 3 |
| 672569 | 24 HR paliperidone 6 MG Extended Release Oral Tablet | SCD | 018cf3ca-bee9-23a6-e063-6394a90ad905 | 3 |
| 672571 | 24 HR paliperidone 9 MG Extended Release Oral Tablet | SCD | 018cf3ca-bee9-23a6-e063-6394a90ad905 | 3 |
| 866103 | paliperidone 1.5 MG 24 HR Extended Release Oral Tablet | SY | 018cf3ca-bee9-23a6-e063-6394a90ad905 | 3 |
| 672567 | paliperidone 3 MG 24 HR Extended Release Oral Tablet | SY | 018cf3ca-bee9-23a6-e063-6394a90ad905 | 3 |
| 672569 | paliperidone 6 MG 24 HR Extended Release Oral Tablet | SY | 018cf3ca-bee9-23a6-e063-6394a90ad905 | 3 |
| 672571 | paliperidone 9 MG 24 HR Extended Release Oral Tablet | SY | 018cf3ca-bee9-23a6-e063-6394a90ad905 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 65162-283-03 | 65162028303 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-283-03) | 2019-09-24 | 0000-00-00 | No | No | Current |
| 65162-283-09 | 65162028309 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-283-09) | 2019-09-24 | 0000-00-00 | No | No | Current |