Prescription drug · ANDA
Loxapine NDC 64850-890
Loxapine succinate 5 mg/1 · Capsule · Oral · Elite Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64850-890-01 | 64850089001 | 100 CAPSULE in 1 BOTTLE (64850-890-01)Marketed from Jan 27, 2020 |
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
- Elite Laboratories, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076868
- Marketing start
- Listing expires
- Identifiers
- Product ID 64850-890_538b7d03-c464-465d-b690-9701c14cf580SPL ID 538b7d03-c464-465d-b690-9701c14cf580SPL set ID a0cc7bb6-075f-47d1-8935-eb77a29d8c45RxCUI 311385, 311386, 314075, 314078UNII X59SG0MRYUUPC 0364850890014, 0364850893015, 0364850892018, 0364850891011
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
N464850089001followed by a unit qualifier and the quantityPackage 64850-0890-01. 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)
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 076868
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 50 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4311 |
| Loxapine | Loxapine succinate 10 mg/1 | CapsuleOral | Elite Laboratories, Inc. | 64850-891 |
| Loxapine | Loxapine succinate 25 mg/1 | CapsuleOral | Elite Laboratories, Inc. | 64850-892 |
| Loxapine | Loxapine succinate 50 mg/1 | CapsuleOral | Elite Laboratories, Inc. | 64850-893 |