Prescription drug · ANDA
Paliperidone NDC 67046-1539
Paliperidone 3 mg/1 · Tablet, Extended release · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1539-3 | 67046153903 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1539-3)Marketed from Mar 25, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Paliperidone
- Generic name (nonproprietary)
- paliperidone
- Active ingredients
- Paliperidone — 3 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Coupler LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204707
- Marketing start
- Listing expires
- Identifiers
- Product ID 67046-1539_31352593-a65e-3b4e-e063-6294a90a49f9SPL ID 31352593-a65e-3b4e-e063-6294a90a49f9SPL set ID 313538c9-01d3-1558-e063-6394a90aa21dRxCUI 672567UNII 838F01T721
- 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
N467046153903followed by a unit qualifier and the quantityPackage 67046-1539-03. 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)
Paliperidone extended-release tablets are 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 to 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 Paliperidone extended-release tablets are indicated for the treatment of schizophrenia [see Clinical Studies (14.1) ]. The efficacy of paliperidone extended-release tablets in schizophrenia was es…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204707
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 |
|---|---|---|---|---|
| Paliperidone | Paliperidone 6 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1630 |
| Paliperidone | Paliperidone 1.5 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 65162-280 |
| Paliperidone | Paliperidone 9 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 65162-283 |
| Paliperidone | Paliperidone 3 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 65162-281 |
| Paliperidone | Paliperidone 6 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 65162-282 |
| Paliperidone | Paliperidone 3 mg/1 | Tablet, Extended releaseOral | AvKARE | 42291-916 |
| Paliperidone | Paliperidone 1.5 mg/1 | Tablet, Extended releaseOral | AvKARE | 42291-915 |
| Paliperidone | Paliperidone 6 mg/1 | Tablet, Extended releaseOral | AvKARE | 42291-917 |
| Paliperidone | Paliperidone 9 mg/1 | Tablet, Extended releaseOral | AvKARE | 42291-918 |