Prescription drug · NDA
Invega Trinza (Paliperidone palmitate) NDC 50458-607
Paliperidone palmitate 410 mg/1.32mL · Injection, Suspension, Extended release · Intramuscular · Janssen Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50458-607-01 | 5045806070150458060701 | 1 SYRINGE in 1 KIT (50458-607-01) / 1 mL in 1 SYRINGEMarketed from May 19, 2015 |
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 Trinza
- Generic name (nonproprietary)
- paliperidone palmitate
- Active ingredients
- Paliperidone palmitate — 410 mg/1.32mL
- Dosage form
- Injection, Suspension, Extended release
- Route
- Intramuscular
- Labeler
- Janssen Pharmaceuticals, IncNDC labeler code 50458
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 207946
- Marketing start
- Listing expires
- Identifiers
- Product ID 50458-607_2e1c6fa0-3051-4a53-e063-6294a90ad1c3SPL ID 2e1c6fa0-3051-4a53-e063-6294a90ad1c3SPL set ID c39e65d7-fa44-4e4c-8b12-a654d3ed0eaeRxCUI 1650966, 1650968, 1650971, 1650972, 1650973, 1650974, 1650975, 1650976UNII R8P8USM8FR
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N450458060701followed by a unit qualifier and the quantityPackage 50458-0607-01. 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 TRINZA (paliperidone palmitate), a 3-month injection, is indicated for the treatment of schizophrenia in patients after they have been adequately treated with INVEGA SUSTENNA (1-month paliperidone palmitate extended-release injectable suspension) for at least four months [see Dosage and Administration (2.2) and Clinical Studies (14) ] . INVEGA TRINZA, a 3-month injection, is an atypical antipsychotic indicated for the treatment of schizophrenia in patients after they have been adequately treated with INVEGA SUSTENNA (1-month paliperidone palmitate extended-release injectable suspension) for at least four months. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 50458-607
- What is NDC 50458-607?
- 50458-607 is the product NDC for Invega Trinza (paliperidone palmitate), Paliperidone palmitate 410 mg/1.32mL injection, suspension, extended release, listed with the FDA by Janssen Pharmaceuticals, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Invega Trinza (Paliperidone palmitate).
- What is the active ingredient?
- Paliperidone palmitate.
- 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 Trinza?
- 3 other product NDCs are listed under this name. See all Invega Trinza NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Invega Trinza products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Invega Trinzapaliperidone palmitate | Paliperidone palmitate 273 mg/.88mL | Injection, Suspension, Extended releaseIntramuscular | Janssen Pharmaceuticals, Inc | 50458-606 | 50458-0606-01 |
| Invega Trinzapaliperidone palmitate | Paliperidone palmitate 546 mg/1.75mL | Injection, Suspension, Extended releaseIntramuscular | Janssen Pharmaceuticals, Inc | 50458-608 | 50458-0608-01 |
| Invega Trinzapaliperidone palmitate | Paliperidone palmitate 819 mg/2.63mL | Injection, Suspension, Extended releaseIntramuscular | Janssen Pharmaceuticals, Inc | 50458-609 | 50458-0609-01 |
Other NDCs under NDA 207946
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 |
|---|---|---|---|---|
| Invega Hafyerapaliperidone palmitate | Paliperidone palmitate 1092 mg/3.5mL | Injection, Suspension, Extended releaseIntramuscular | Janssen Pharmaceuticals, Inc | 50458-611 |
| Invega Hafyerapaliperidone palmitate | Paliperidone palmitate 1560 mg/5mL | Injection, Suspension, Extended releaseIntramuscular | Janssen Pharmaceuticals, Inc | 50458-612 |
| Invega Trinzapaliperidone palmitate | Paliperidone palmitate 273 mg/.88mL | Injection, Suspension, Extended releaseIntramuscular | Janssen Pharmaceuticals, Inc | 50458-606 |
| Invega Trinzapaliperidone palmitate | Paliperidone palmitate 546 mg/1.75mL | Injection, Suspension, Extended releaseIntramuscular | Janssen Pharmaceuticals, Inc | 50458-608 |
| Invega Trinzapaliperidone palmitate | Paliperidone palmitate 819 mg/2.63mL | Injection, Suspension, Extended releaseIntramuscular | Janssen Pharmaceuticals, Inc | 50458-609 |