Prescription drug · NDA
Juxtapid (lomitapide mesylate) NDC 10122-430
Lomitapide mesylate 30 mg/1 · Capsule · Oral · Chiesi USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10122-430-28 | 10122043028 | 28 CAPSULE in 1 BOTTLE (10122-430-28)Marketed from Jun 22, 2015 |
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)
- Juxtapid
- Generic name (nonproprietary)
- lomitapide mesylate
- Active ingredients
- Lomitapide mesylate — 30 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Chiesi USA, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 203858
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 3A4 Inhibitors (Mechanism)Microsomal Triglyceride Transfer Protein Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 10122-430_b2c29de4-7331-4670-998a-69c91ad2fa7fSPL ID b2c29de4-7331-4670-998a-69c91ad2fa7fSPL set ID 61a0be9d-ee58-43e0-b5cb-141011835081RxCUI 1364484, 1364490, 1364492, 1364494, 1364496, 1364498, 1648770, 1648772, 2738809, 2738811UNII X4S83CP54EUPC 0310122410282, 0310122405288, 0310122402287, 0310122430280, 0310122420281
- Pharmacologic class
- Microsomal Triglyceride Transfer Protein Inhibitor
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
N410122043028followed by a unit qualifier and the quantityPackage 10122-0430-28. 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)
JUXTAPID is indicated as an adjunct to a low-fat diet and exercise and other low density lipoprotein cholesterol (LDL-C) therapies to reduce LDL-C in adults and pediatric patients aged 2 years and older with homozygous familial hypercholesterolemia (HoFH). JUXTAPID is a microsomal triglyceride transfer protein inhibitor indicated as an adjunct to a low-fat diet and exercise and other low-density lipoprotein cholesterol (LDL-C) therapies, to reduce LDL-C in adult and pediatric patients aged 2 years and older with HoFH. ( 1 ).
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 203858
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 |
|---|---|---|---|---|
| Juxtapidlomitapide mesylate | Lomitapide mesylate 10 mg/1 | CapsuleOral | Amryt Pharmaceuticals DAC | 76431-110 |
| Juxtapidlomitapide mesylate | Lomitapide mesylate 20 mg/1 | CapsuleOral | Amryt Pharmaceuticals DAC | 76431-120 |
| Juxtapidlomitapide mesylate | Lomitapide mesylate 2 mg/1 | CapsuleOral | Chiesi USA, Inc. | 10122-402 |
| Juxtapidlomitapide mesylate | Lomitapide mesylate 5 mg/1 | CapsuleOral | Chiesi USA, Inc. | 10122-405 |
| Juxtapidlomitapide mesylate | Lomitapide mesylate 10 mg/1 | CapsuleOral | Chiesi USA, Inc. | 10122-410 |
| Juxtapidlomitapide mesylate | Lomitapide mesylate 20 mg/1 | CapsuleOral | Chiesi USA, Inc. | 10122-420 |