Prescription drug · NDA
Invega Sustenna (Paliperidone palmitate) NDC 50458-563
Paliperidone palmitate 156 mg/mL · Injection · Intramuscular · Janssen Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50458-563-01 | 5045805630150458056301 | 1 SYRINGE in 1 KIT (50458-563-01) / 1 mL in 1 SYRINGEMarketed from Jul 31, 2009 | |
| 50458-563-03 | 5045805630350458056303 | 1 SYRINGE in 1 KIT (50458-563-03) / 1 mL in 1 SYRINGEMarketed from Jul 31, 2009 · Sample package |
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 Sustenna
- Generic name (nonproprietary)
- paliperidone palmitate
- Active ingredients
- Paliperidone palmitate — 156 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular
- Labeler
- Janssen Pharmaceuticals, Inc.NDC labeler code 50458
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022264
- Marketing start
- Listing expires
- Identifiers
- Product ID 50458-563_2e1c43cb-d27e-b3ac-e063-6394a90ad44aSPL ID 2e1c43cb-d27e-b3ac-e063-6394a90ad44aSPL set ID 1af14e42-951d-414d-8564-5d5fce138554RxCUI 858048, 858051, 858052, 858053, 858054, 858055, 858056, 858057, 858073, 858074UNII 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
N450458056301followed by a unit qualifier and the quantityPackage 50458-0563-01. 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 SUSTENNA (paliperidone palmitate) is indicated for the treatment of: Schizophrenia in adults [see Clinical Studies (14.1) ]. Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants [see Clinical Studies (14.2) ]. INVEGA SUSTENNA is an atypical antipsychotic indicated for Treatment of schizophrenia in adults. ( 1 ) Treatment of schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 50458-563
- What is NDC 50458-563?
- 50458-563 is the product NDC for Invega Sustenna (paliperidone palmitate), Paliperidone palmitate 156 mg/mL injection, 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 Sustenna (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 Sustenna?
- 4 other product NDCs are listed under this name. See all Invega Sustenna NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Invega Sustenna 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 Sustennapaliperidone palmitate | Paliperidone palmitate 39 mg/.25mL | InjectionIntramuscular | Janssen Pharmaceuticals, Inc. | 50458-560 | 50458-0560-01 |
| Invega Sustennapaliperidone palmitate | Paliperidone palmitate 78 mg/.5mL | InjectionIntramuscular | Janssen Pharmaceuticals, Inc. | 50458-561 | 50458-0561-01 |
| Invega Sustennapaliperidone palmitate | Paliperidone palmitate 117 mg/.75mL | InjectionIntramuscular | Janssen Pharmaceuticals, Inc. | 50458-562 | 50458-0562-01 |
| Invega Sustennapaliperidone palmitate | Paliperidone palmitate 234 mg/1.5mL | InjectionIntramuscular | Janssen Pharmaceuticals, Inc. | 50458-564 | 50458-0564-0150458-0564-03 |
Other NDCs under NDA 022264
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 Sustennapaliperidone palmitate | Paliperidone palmitate 39 mg/.25mL | InjectionIntramuscular | Janssen Pharmaceuticals, Inc. | 50458-560 |
| Invega Sustennapaliperidone palmitate | Paliperidone palmitate 78 mg/.5mL | InjectionIntramuscular | Janssen Pharmaceuticals, Inc. | 50458-561 |
| Invega Sustennapaliperidone palmitate | Paliperidone palmitate 117 mg/.75mL | InjectionIntramuscular | Janssen Pharmaceuticals, Inc. | 50458-562 |
| Invega Sustennapaliperidone palmitate | Paliperidone palmitate 234 mg/1.5mL | InjectionIntramuscular | Janssen Pharmaceuticals, Inc. | 50458-564 |