Prescription drug · NDA
Invega (paliperidone) NDC 50458-554
Paliperidone 1.5 mg/1 · Tablet, Extended release · Oral · Janssen Pharmaceuticals, Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Invega
- Generic name (nonproprietary)
- paliperidone
- Active ingredients
- Paliperidone — 1.5 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021999
- Marketing start
- Listing expires
- Identifiers
- Product ID 50458-554_3c5e5b30-a841-4dfe-88ce-361806c9275fSPL ID 3c5e5b30-a841-4dfe-88ce-361806c9275fSPL set ID 7b8e5b26-b9e4-4704-921b-3c3c0d159916RxCUI 672567, 672569, 672571, 686441, 686443, 686445, 866103, 866105UNII 838F01T721UPC 0350458552010, 0350458551013, 0350458550016
- Pharmacologic class
- Atypical Antipsychotic
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INVEGA is an atypical antipsychotic agent indicated for Treatment of schizophrenia ( 1.1 ) Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1 ) Adolescents (ages 12–17): Efficacy was established in one 6-week trial. ( 14.1 ) Treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants. ( 1.2 ) Efficacy was established in two 6-week trials in adult patients. ( 14.2 ) 1.1 Schizophrenia INVEGA (paliperidone) Extended-Release Tablets are indicated for the treatment of schizophrenia [see Clinical Studies (14.1) ] . The efficacy of INVEGA in schizophrenia was established in three 6-week trials in adults and…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021999
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Invegapaliperidone | Paliperidone 9 mg/1 | Tablet, Extended releaseOral | Janssen Pharmaceuticals, Inc. | 50458-552 |
| Invegapaliperidone | Paliperidone 3 mg/1 | Tablet, Extended releaseOral | Janssen Pharmaceuticals, Inc. | 50458-550 |
| Invegapaliperidone | Paliperidone 6 mg/1 | Tablet, Extended releaseOral | Janssen Pharmaceuticals, Inc. | 50458-551 |