Prescription drug · NDA
Invega Hafyera (Paliperidone palmitate) NDC 50458-611
Paliperidone palmitate 1092 mg/3.5mL · Injection, Suspension, Extended release · Intramuscular · Janssen Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50458-611-01 | 5045806110150458061101 | 1 SYRINGE in 1 CARTON (50458-611-01) / 3.5 mL in 1 SYRINGEMarketed from Aug 30, 2021 |
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 Hafyera
- Generic name (nonproprietary)
- paliperidone palmitate
- Active ingredients
- Paliperidone palmitate — 1092 mg/3.5mL
- 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 50458-611_2e6ef0e1-19d2-7d78-e063-6394a90ae8a6SPL ID 2e6ef0e1-19d2-7d78-e063-6394a90ae8a6SPL set ID 6cd61892-d2cb-434d-83ed-5c1b2c4e7a0bRxCUI 2570418, 2570419, 2570420, 2570421UNII 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
N450458061101followed by a unit qualifier and the quantityPackage 50458-0611-01. 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 HAFYERA, an every-six-month injection, is indicated for the treatment of schizophrenia in adults after they have been adequately treated with: A once-a-month paliperidone palmitate extended-release injectable suspension (e.g., INVEGA SUSTENNA) for at least four months, or An every-three-month paliperidone palmitate extended-release injectable suspension (e.g., INVEGA TRINZA) for at least one three-month cycle. INVEGA HAFYERA, an every-six-month injection, is an atypical antipsychotic indicated for the treatment of schizophrenia in adults after they have been adequately treated with: A once-a-month paliperidone palmitate extended-release injectable suspension (e.g., INVEGA SUSTENNA) fo…
Excerpt only. Read the full label for complete information.
About NDC 50458-611
- What is NDC 50458-611?
- 50458-611 is the product NDC for Invega Hafyera (paliperidone palmitate), Paliperidone palmitate 1092 mg/3.5mL 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 Hafyera (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 Hafyera?
- 1 other product NDC are listed under this name. See all Invega Hafyera NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Invega Hafyera 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 Hafyerapaliperidone palmitate | Paliperidone palmitate 1560 mg/5mL | Injection, Suspension, Extended releaseIntramuscular | Janssen Pharmaceuticals, Inc | 50458-612 | 50458-0612-01 |
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 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 410 mg/1.32mL | Injection, Suspension, Extended releaseIntramuscular | Janssen Pharmaceuticals, Inc | 50458-607 |
| 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 |