PALIPERIDONE
- Product NDC
- 49252-035
- 11-digit product format
- 492520035
- Labeler code
- 49252
- Product ID
- 49252-035_05e67b7a-0134-451c-b344-8d9adacbae59
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PALIPERIDONE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Inventia Healthcare Limited
- Application
- ANDA204452
- Marketing category
- ANDA
- Marketing start
- 2019-09-01
- Marketing end
- 0000-00-00
- Substance
- PALIPERIDONE
- Active strength
- 9 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49252-035-10 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5066-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use PALIPERIDONE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PALIPERIDONE EXTENDED-RELEASE TABLETS. PALIPERIDONE extended-release tablets, for oral use Initial U.S. Approval: 2006 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49252-035-10 | PALIPERIDONE | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 1 |
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 | 9c2593ed-4551-4921-a82e-24a727712113 | 1 |
| 672567 | paliperidone 3 MG 24HR Extended Release Oral Tablet | PSN | 9c2593ed-4551-4921-a82e-24a727712113 | 1 |
| 672569 | paliperidone 6 MG 24HR Extended Release Oral Tablet | PSN | 9c2593ed-4551-4921-a82e-24a727712113 | 1 |
| 672571 | paliperidone 9 MG 24HR Extended Release Oral Tablet | PSN | 9c2593ed-4551-4921-a82e-24a727712113 | 1 |
| 866103 | 24 HR paliperidone 1.5 MG Extended Release Oral Tablet | SCD | 9c2593ed-4551-4921-a82e-24a727712113 | 1 |
| 672567 | 24 HR paliperidone 3 MG Extended Release Oral Tablet | SCD | 9c2593ed-4551-4921-a82e-24a727712113 | 1 |
| 672569 | 24 HR paliperidone 6 MG Extended Release Oral Tablet | SCD | 9c2593ed-4551-4921-a82e-24a727712113 | 1 |
| 672571 | 24 HR paliperidone 9 MG Extended Release Oral Tablet | SCD | 9c2593ed-4551-4921-a82e-24a727712113 | 1 |
| 866103 | paliperidone 1.5 MG 24 HR Extended Release Oral Tablet | SY | 9c2593ed-4551-4921-a82e-24a727712113 | 1 |
| 672567 | paliperidone 3 MG 24 HR Extended Release Oral Tablet | SY | 9c2593ed-4551-4921-a82e-24a727712113 | 1 |
| 672569 | paliperidone 6 MG 24 HR Extended Release Oral Tablet | SY | 9c2593ed-4551-4921-a82e-24a727712113 | 1 |
| 672571 | paliperidone 9 MG 24 HR Extended Release Oral Tablet | SY | 9c2593ed-4551-4921-a82e-24a727712113 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 49252-035-10 | 49252003510 | 30 in 1 BOTTLE | Historical |