Prescription drug · ANDA
paliperidone NDC 62332-804
Paliperidone 3 mg/1 · Tablet, Extended release · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-804-30 | 62332080430 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-804-30)Marketed from Sep 30, 2024 |
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
- Alembic Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218330
- Marketing start
- Listing expires
- Identifiers
- Product ID 62332-804_7f2fd92d-4305-4048-b47e-c8fa018fa341SPL ID 7f2fd92d-4305-4048-b47e-c8fa018fa341SPL set ID 45fc28d1-132f-413b-a407-dc90e1229ee2RxCUI 672567, 672569, 672571, 866103UNII 838F01T721UPC 0362332805303
- 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
N462332080430followed by a unit qualifier and the quantityPackage 62332-0804-30. 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 tablet 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 schizop…
Excerpt only. Read the full label for complete information.