paliperidone
- Product NDC
- 62332-803
- 11-digit product format
- 623320803
- Labeler code
- 62332
- Product ID
- 62332-803_7f2fd92d-4305-4048-b47e-c8fa018fa341
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paliperidone
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA218330
- Marketing category
- ANDA
- Marketing start
- 2024-09-30
- Substance
- PALIPERIDONE
- Active strength
- 1.5 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 | 1.5 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 |
| fd328049-536a-4914-b42e-93bf4d93db24 | Product name | 1 | 20220307 |
| 0f0756fc-4d63-4f75-afcc-9c5e62a38d69 | Product name | 2 | 20220304 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62332-803-30 | paliperidone | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 62332-803-30 | EA - Each | 62332-803 | 39b9f29d-c2d4-4fd7-8fef-eba2e031806f | 1 | 2025-10-14 |
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 | 45fc28d1-132f-413b-a407-dc90e1229ee2 | 5 |
| 672567 | paliperidone 3 MG 24HR Extended Release Oral Tablet | PSN | 45fc28d1-132f-413b-a407-dc90e1229ee2 | 5 |
| 672569 | paliperidone 6 MG 24HR Extended Release Oral Tablet | PSN | 45fc28d1-132f-413b-a407-dc90e1229ee2 | 5 |
| 672571 | paliperidone 9 MG 24HR Extended Release Oral Tablet | PSN | 45fc28d1-132f-413b-a407-dc90e1229ee2 | 5 |
| 866103 | 24 HR paliperidone 1.5 MG Extended Release Oral Tablet | SCD | 45fc28d1-132f-413b-a407-dc90e1229ee2 | 5 |
| 672567 | 24 HR paliperidone 3 MG Extended Release Oral Tablet | SCD | 45fc28d1-132f-413b-a407-dc90e1229ee2 | 5 |
| 672569 | 24 HR paliperidone 6 MG Extended Release Oral Tablet | SCD | 45fc28d1-132f-413b-a407-dc90e1229ee2 | 5 |
| 672571 | 24 HR paliperidone 9 MG Extended Release Oral Tablet | SCD | 45fc28d1-132f-413b-a407-dc90e1229ee2 | 5 |
| 866103 | paliperidone 1.5 MG 24 HR Extended Release Oral Tablet | SY | 45fc28d1-132f-413b-a407-dc90e1229ee2 | 5 |
| 672567 | paliperidone 3 MG 24 HR Extended Release Oral Tablet | SY | 45fc28d1-132f-413b-a407-dc90e1229ee2 | 5 |
| 672569 | paliperidone 6 MG 24 HR Extended Release Oral Tablet | SY | 45fc28d1-132f-413b-a407-dc90e1229ee2 | 5 |
| 672571 | paliperidone 9 MG 24 HR Extended Release Oral Tablet | SY | 45fc28d1-132f-413b-a407-dc90e1229ee2 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 62332-803-30 | 62332080330 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-803-30) | 2024-09-30 | No | No | Current |