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NDC 65162-0281-09 Paliperidone 3 mg/1 Details
Paliperidone 3 mg/1
Paliperidone is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is PALIPERIDONE.
MedlinePlus Drug Summary
Paliperidone is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). Paliperidone is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.
Related Packages: 65162-0281-09Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Paliperidone
Product Information
| NDC | 65162-0281 |
|---|---|
| Product ID | 65162-281_ca26f93a-2ccd-4fe7-9537-fd2233bd59ad |
| Associated GPIs | 59070050007510 |
| GCN Sequence Number | 061985 |
| GCN Sequence Number Description | paliperidone TAB ER 24 3 MG ORAL |
| HIC3 | H7T |
| HIC3 Description | ANTIPSYCHOTIC,ATYPICAL,DOPAMINE,SEROTONIN ANTAGNST |
| GCN | 97769 |
| HICL Sequence Number | 034343 |
| HICL Sequence Number Description | PALIPERIDONE |
| Brand/Generic | Generic |
| Proprietary Name | Paliperidone |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Paliperidone |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 3 |
| Active Ingredient Units | mg/1 |
| Substance Name | PALIPERIDONE |
| Labeler Name | Amneal Pharmaceuticals LLC |
| Pharmaceutical Class | Atypical Antipsychotic [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA204707 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65162-0281-09 (65162028109)
| NDC Package Code | 65162-281-09 |
|---|---|
| Billing NDC | 65162028109 |
| Package | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-281-09) |
| Marketing Start Date | 2019-09-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |