Prescription drug · ANDA
Paliperidone NDC 16714-867
Paliperidone 3 mg/1 · Tablet, Film coated, Extended release · Oral · NorthStar RxLLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-867-01 | 16714086701 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16714-867-01)Marketed from Oct 15, 2018 |
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, Film coated, Extended release
- Route
- Oral
- Labeler
- NorthStar RxLLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205618
- Marketing start
- Listing expires
- Identifiers
- Product ID 16714-867_d8ce0982-0101-48f6-a85c-8b2c8c8fd0d9SPL ID d8ce0982-0101-48f6-a85c-8b2c8c8fd0d9SPL set ID 5589ec69-c49c-44a7-9561-bbffeb918d1fRxCUI 672567, 672569, 672571, 866103UNII 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
N416714086701followed by a unit qualifier and the quantityPackage 16714-0867-01. 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)
Paliperidone is 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 established…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205618
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 9 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4267 |
| Paliperidone | Paliperidone 6 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4268 |
| Paliperidone | Paliperidone 3 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4269 |
| Paliperidone | Paliperidone 9 mg/1 | Tablet, Film coated, Extended releaseOral | NorthStar RxLLC | 16714-869 |
| Paliperidone | Paliperidone 1.5 mg/1 | Tablet, Film coated, Extended releaseOral | NorthStar RxLLC | 16714-866 |
| Paliperidone | Paliperidone 6 mg/1 | Tablet, Film coated, Extended releaseOral | NorthStar RxLLC | 16714-868 |
| Paliperidone | Paliperidone 1.5 mg/1 | Tablet, Film coated, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 47335-744 |
| Paliperidone | Paliperidone 3 mg/1 | Tablet, Film coated, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 47335-765 |
| Paliperidone | Paliperidone 6 mg/1 | Tablet, Film coated, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 47335-766 |
| Paliperidone | Paliperidone 9 mg/1 | Tablet, Film coated, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 47335-767 |
| Paliperidone | Paliperidone 3 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-6935 |
| Paliperidone | Paliperidone 6 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-6936 |
| Paliperidone | Paliperidone 9 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-6937 |
| Paliperidone | Paliperidone 3 mg/1 | Tablet, Extended releaseOral | American Health Packaging | 60687-459 |
| Paliperidone | Paliperidone 6 mg/1 | Tablet, Extended releaseOral | American Health Packaging | 60687-470 |