Prescription drug · ANDA
Loxapine NDC 62135-492
Loxapine succinate 5 mg/1 · Capsule · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-492-60 | 62135049260 | 60 CAPSULE in 1 BOTTLE (62135-492-60)Marketed from Mar 1, 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)
- Loxapine
- Generic name (nonproprietary)
- loxapine
- Active ingredients
- Loxapine succinate — 5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090695
- Marketing start
- Listing expires
- Identifiers
- Product ID 62135-492_456ed50c-28f9-4af8-e063-6394a90a23f1SPL ID 456ed50c-28f9-4af8-e063-6394a90a23f1SPL set ID 3e412c36-66b0-444b-833b-cea79976844eRxCUI 311386, 314078UNII X59SG0MRYUUPC 0362135493608, 0362135492601
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
N462135049260followed by a unit qualifier and the quantityPackage 62135-0492-60. 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)
INDICATIONS AND USAGE Loxapine Capsules are indicated for the treatment of schizophrenia. The efficacy of loxapine in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized acutely ill schizophrenic patients as subjects.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090695
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 |
|---|---|---|---|---|
| Loxapine | Loxapine succinate 25 mg/1 | CapsuleOral | Lannett Company, Inc. | 0527-1396 |
| Loxapine | Loxapine succinate 10 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-493 |
| Loxapine | Loxapine succinate 25 mg/1 | CapsuleOral | Coupler LLC | 67046-1478 |
| Loxapine | Loxapine succinate 5 mg/1 | CapsuleOral | Coupler LLC | 67046-1479 |
| Loxapine | Loxapine succinate 50 mg/1 | CapsuleOral | Lannett Company, Inc. | 0527-1397 |
| Loxapine | Loxapine succinate 10 mg/1 | CapsuleOral | Coupler LLC | 67046-1485 |
| Loxapine | Loxapine succinate 5 mg/1 | CapsuleOral | Proficient Rx LP | 82804-051 |
| Loxapine | Loxapine succinate 10 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-1681 |
| Loxapine | Loxapine succinate 50 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-1792 |
| Loxapine | Loxapine succinate 5 mg/1 | CapsuleOral | Lannett Company, Inc. | 0527-1394 |
| Loxapine | Loxapine succinate 10 mg/1 | CapsuleOral | Lannett Company, Inc. | 0527-1395 |
| Loxapine | Loxapine succinate 25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-1896 |