Paliperidone is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Inc.. The primary component is Paliperidone.
| Product ID | 42292-055_a070d4e7-e6ee-7dda-e053-2a95a90a3b1b |
| NDC | 42292-055 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Paliperidone |
| Generic Name | Paliperidone |
| Dosage Form | Tablet, Film Coated, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-03-06 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA203802 |
| Labeler Name | Mylan Institutional Inc. |
| Substance Name | PALIPERIDONE |
| Active Ingredient Strength | 9 mg/1 |
| Pharm Classes | Atypical Antipsychotic [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2020-03-06 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA203802 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2020-03-06 |
| Marketing Category | ANDA |
| Application Number | ANDA203802 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2020-03-06 |
| Ingredient | Strength |
|---|---|
| PALIPERIDONE | 9 mg/1 |
| SPL SET ID: | 7d1467cd-7bde-44d5-befd-817d63e1d746 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0378-3978 | Paliperidone | paliperidone |
| 0378-3979 | Paliperidone | paliperidone |
| 0378-3980 | Paliperidone | paliperidone |
| 0378-3981 | Paliperidone | paliperidone |
| 0591-3692 | Paliperidone | Paliperidone |
| 0591-3693 | Paliperidone | Paliperidone |
| 0591-3694 | Paliperidone | Paliperidone |
| 0591-3695 | Paliperidone | Paliperidone |
| 0904-6935 | Paliperidone | Paliperidone |
| 0904-6936 | Paliperidone | Paliperidone |
| 0904-6937 | Paliperidone | Paliperidone |
| 10147-0951 | Paliperidone | paliperidone |
| 10147-0952 | Paliperidone | paliperidone |
| 10147-0953 | Paliperidone | paliperidone |
| 68151-5041 | Paliperidone | Paliperidone |
| 70518-0850 | Paliperidone | Paliperidone |
| 10147-0954 | Paliperidone | Paliperidone |
| 16714-867 | Paliperidone | Paliperidone |
| 16714-869 | Paliperidone | Paliperidone |
| 16714-866 | Paliperidone | Paliperidone |
| 16714-868 | Paliperidone | Paliperidone |
| 42292-026 | Paliperidone | Paliperidone |
| 42292-027 | Paliperidone | Paliperidone |
| 47335-767 | Paliperidone | Paliperidone |
| 47335-766 | Paliperidone | Paliperidone |
| 47335-765 | Paliperidone | Paliperidone |
| 47335-744 | Paliperidone | Paliperidone |
| 70518-2034 | Paliperidone | Paliperidone |
| 70518-2197 | Paliperidone | Paliperidone |
| 65162-280 | Paliperidone | Paliperidone |
| 65162-281 | Paliperidone | Paliperidone |
| 65162-282 | Paliperidone | Paliperidone |
| 65162-283 | Paliperidone | Paliperidone |
| 49252-033 | PALIPERIDONE | PALIPERIDONE |
| 49252-035 | PALIPERIDONE | PALIPERIDONE |
| 49252-034 | PALIPERIDONE | PALIPERIDONE |
| 49252-032 | PALIPERIDONE | PALIPERIDONE |
| 60687-459 | Paliperidone | Paliperidone |
| 60687-470 | Paliperidone | Paliperidone |
| 43975-350 | PALIPERIDONE | PALIPERIDONE |
| 43975-352 | PALIPERIDONE | PALIPERIDONE |
| 43975-349 | PALIPERIDONE | PALIPERIDONE |
| 43975-351 | PALIPERIDONE | PALIPERIDONE |
| 42292-055 | Paliperidone | Paliperidone |
| 70518-2509 | Paliperidone | Paliperidone |