Prescription drug · ANDA
Paliperidone NDC 31722-318
Paliperidone 3 mg/1 · Tablet, Extended release · Oral · Camber Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-318-30 | 31722031830 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-318-30)Marketed from Aug 23, 2023 |
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
- Camber Pharmaceuticals, IncNDC labeler code 31722
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216174
- Marketing start
- Listing expires
- Identifiers
- Product ID 31722-318_a6b46674-2b24-4485-9d9f-7f4bcfb20ae3SPL ID a6b46674-2b24-4485-9d9f-7f4bcfb20ae3SPL set ID 1cfcad42-da71-457d-b1e1-aee806642d0cRxCUI 672567, 672569, 672571, 866103UNII 838F01T721UPC 0331722317306, 0331722320306, 0331722318303, 0331722319300
- 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
N431722031830followed by a unit qualifier and the quantityPackage 31722-0318-30. 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 12-17): 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 in schizophrenia was established in three 6-week tr…
Excerpt only. Read the full label for complete information.
About NDC 31722-318
- What is NDC 31722-318?
- 31722-318 is the product NDC for Paliperidone, Paliperidone 3 mg/1 tablet, extended release, listed with the FDA by Camber Pharmaceuticals, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Paliperidone.
- What is the active ingredient?
- Paliperidone.
- Who is the labeler?
- Camber Pharmaceuticals, Inc, NDC labeler code 31722. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Paliperidone?
- 64 other product NDCs are listed under this name. See all Paliperidone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Paliperidone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Paliperidone | Paliperidone 6 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1630 | 67046-1630-03 |
| Paliperidone | Paliperidone 3 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2649 | 72162-2649-03 |
| Paliperidone | Paliperidone 6 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2650 | 72162-2650-03 |
| Paliperidone | Paliperidone 9 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2651 | 72162-2651-03 |
| Paliperidone | Paliperidone 1.5 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2648 | 72162-2648-03 |
| Paliperidone | Paliperidone 3 mg/1 | Tablet, Extended releaseOral | Westminster Pharmaceuticals, LLC | 69367-433 | 69367-0433-30 |
| Paliperidone | Paliperidone 1.5 mg/1 | Tablet, Extended releaseOral | Westminster Pharmaceuticals, LLC | 69367-432 | 69367-0432-30 |
| Paliperidone | Paliperidone 6 mg/1 | Tablet, Extended releaseOral | Westminster Pharmaceuticals, LLC | 69367-434 | 69367-0434-30 |
| Paliperidone | Paliperidone 9 mg/1 | Tablet, Extended releaseOral | Westminster Pharmaceuticals, LLC | 69367-435 | 69367-0435-30 |
| Paliperidone | Paliperidone 1.5 mg/1 | Tablet, Extended releaseOral | Eskayef Pharmaceuticals Limited | 72658-1253 | 72658-1253-0172658-1253-0272658-1253-03 |
Other NDCs under ANDA 216174
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 | Camber Pharmaceuticals, Inc | 31722-319 |
| Paliperidone | Paliperidone 9 mg/1 | Tablet, Extended releaseOral | Camber Pharmaceuticals, Inc | 31722-320 |
| Paliperidone | Paliperidone 1.5 mg/1 | Tablet, Extended releaseOral | Camber Pharmaceuticals, Inc | 31722-317 |