Prescription drug · ANDA
Paliperidone NDC 65162-281
Paliperidone 3 mg/1 · Tablet, Extended release · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-281-03 | 65162028103 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-281-03)Marketed from Sep 24, 2019 | |
| 65162-281-09 | 65162028109 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-281-09)Marketed from Sep 24, 2019 |
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)
- Paliperidone
- Generic name (nonproprietary)
- paliperidone
- Active ingredients
- Paliperidone — 3 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204707
- Marketing start
- Listing expires
- Identifiers
- Product ID 65162-281_d01cb993-8ed1-4746-ad80-d95d3025c3acSPL ID d01cb993-8ed1-4746-ad80-d95d3025c3acSPL set ID 7b269778-803b-4ce2-a8c0-636fb131d16aRxCUI 672567, 672569, 672571, 866103UNII 838F01T721UPC 0365162280036, 0365162282030, 0365162281033, 0365162283037
- 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
N465162028103followed by a unit qualifier and the quantityPackage 65162-0281-03. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 3 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1539 |
| 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 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 |