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
- Labeler
- Janssen Pharmaceuticals, Inc.NDC labeler code 50458
- 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.
About NDC 50458-554
- What is NDC 50458-554?
- 50458-554 is the product NDC for Invega (paliperidone), Paliperidone 1.5 mg/1 tablet, extended release, listed with the FDA by Janssen Pharmaceuticals, Inc..
- What drug is associated with this NDC?
- Invega (Paliperidone).
- What is the active ingredient?
- Paliperidone.
- Who is the labeler?
- Janssen Pharmaceuticals, Inc., NDC labeler code 50458. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Invega?
- 3 other product NDCs are listed under this name. See all Invega NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Invega products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Invegapaliperidone | Paliperidone 6 mg/1 | Tablet, Extended releaseOral | Janssen Pharmaceuticals, Inc. | 50458-551 | 50458-0551-0150458-0551-98 |
| Invegapaliperidone | Paliperidone 3 mg/1 | Tablet, Extended releaseOral | Janssen Pharmaceuticals, Inc. | 50458-550 | 50458-0550-0150458-0550-98 |
| Invegapaliperidone | Paliperidone 9 mg/1 | Tablet, Extended releaseOral | Janssen Pharmaceuticals, Inc. | 50458-552 | 50458-0552-0150458-0552-98 |
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 3 mg/1 | Tablet, Extended releaseOral | Janssen Pharmaceuticals, Inc. | 50458-550 |
| Invegapaliperidone | Paliperidone 6 mg/1 | Tablet, Extended releaseOral | Janssen Pharmaceuticals, Inc. | 50458-551 |
| Invegapaliperidone | Paliperidone 9 mg/1 | Tablet, Extended releaseOral | Janssen Pharmaceuticals, Inc. | 50458-552 |