Prescription drug · NDA
Invega (Paliperidone) NDC 50458-550
Paliperidone 3 mg/1 · Tablet, Extended release · Oral · Janssen Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50458-550-01 | 50458055001 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-550-01)Marketed from Dec 19, 2006 | |
| 50458-550-98 | 50458055098 | 7 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-550-98)Marketed from Dec 19, 2006 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Invega
- Generic name (nonproprietary)
- paliperidone
- Active ingredients
- Paliperidone — 3 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 50458-550_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.
- NDC on a medical claim
N450458055001followed by a unit qualifier and the quantityPackage 50458-0550-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
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 50458-550
- What is NDC 50458-550?
- 50458-550 is the product NDC for Invega (paliperidone), Paliperidone 3 mg/1 tablet, extended release, listed with the FDA by Janssen Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- 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 1.5 mg/1 | Tablet, Extended releaseOral | Janssen Pharmaceuticals, Inc. | 50458-554 | — |
| Invegapaliperidone | Paliperidone 6 mg/1 | Tablet, Extended releaseOral | Janssen Pharmaceuticals, Inc. | 50458-551 | 50458-0551-0150458-0551-98 |
| 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 6 mg/1 | Tablet, Extended releaseOral | Janssen Pharmaceuticals, Inc. | 50458-551 |
| Invegapaliperidone | Paliperidone 9 mg/1 | Tablet, Extended releaseOral | Janssen Pharmaceuticals, Inc. | 50458-552 |
| Invegapaliperidone | Paliperidone 1.5 mg/1 | Tablet, Extended releaseOral | Janssen Pharmaceuticals, Inc. | 50458-554 |