Prescription drug · ANDA
Loxapine NDC 0527-1394
Loxapine succinate 5 mg/1 · Capsule · Oral · Lannett Company, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0527-1394-01 | 0052713940100527139401 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0527-1394-01)Marketed from Sep 26, 2011 | |
| 0527-1394-10 | 0052713941000527139410 | 1000 CAPSULE in 1 BOTTLE, PLASTIC (0527-1394-10)Marketed from Sep 26, 2011 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Lannett Company, Inc.NDC labeler code 0527
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090695
- Marketing start
- Listing expires
- Identifiers
- Product ID 0527-1394_d237714b-55f8-4a6e-9297-c10d41ab3cd2SPL ID d237714b-55f8-4a6e-9297-c10d41ab3cd2SPL set ID 509bad3c-b563-4042-b270-d28bde19f224RxCUI 311385, 311386, 314075, 314078UNII X59SG0MRYUUPC 0305271397010, 0305271396013
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
N400527139401followed by a unit qualifier and the quantityPackage 00527-1394-01. 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, USP 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.
About NDC 0527-1394
- What is NDC 0527-1394?
- 0527-1394 is the product NDC for Loxapine, Loxapine succinate 5 mg/1 capsule, listed with the FDA by Lannett Company, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Loxapine.
- What is the active ingredient?
- Loxapine succinate.
- Who is the labeler?
- Lannett Company, Inc., NDC labeler code 0527. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Loxapine?
- 21 other product NDCs are listed under this name. See all Loxapine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Loxapine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Loxapine | Loxapine succinate 50 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4311 | 70518-4311-00 |
| Loxapine | Loxapine succinate 25 mg/1 | CapsuleOral | Coupler LLC | 67046-1478 | 67046-1478-03 |
| Loxapine | Loxapine succinate 5 mg/1 | CapsuleOral | Coupler LLC | 67046-1479 | 67046-1479-03 |
| Loxapine | Loxapine succinate 10 mg/1 | CapsuleOral | Coupler LLC | 67046-1485 | 67046-1485-03 |
| Loxapine | Loxapine succinate 5 mg/1 | CapsuleOral | Elite Laboratories, Inc. | 64850-890 | 64850-0890-01 |
| Loxapine | Loxapine succinate 10 mg/1 | CapsuleOral | Elite Laboratories, Inc. | 64850-891 | 64850-0891-01 |
| Loxapine | Loxapine succinate 25 mg/1 | CapsuleOral | Elite Laboratories, Inc. | 64850-892 | 64850-0892-01 |
| Loxapine | Loxapine succinate 50 mg/1 | CapsuleOral | Elite Laboratories, Inc. | 64850-893 | 64850-0893-01 |
| Loxapine | Loxapine succinate 25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-1896 | 70518-1896-00 |
| Loxapine | Loxapine succinate 50 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-1792 | 70518-1792-0070518-1792-01 |
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 10 mg/1 | CapsuleOral | Lannett Company, Inc. | 0527-1395 |
| Loxapine | Loxapine succinate 25 mg/1 | CapsuleOral | Lannett Company, Inc. | 0527-1396 |
| Loxapine | Loxapine succinate 50 mg/1 | CapsuleOral | Lannett Company, Inc. | 0527-1397 |
| Loxapine | Loxapine succinate 5 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-492 |
| 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 10 mg/1 | CapsuleOral | Coupler LLC | 67046-1485 |
| 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 25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-1896 |
| Loxapine | Loxapine succinate 5 mg/1 | CapsuleOral | Proficient Rx LP | 82804-051 |