Prescription drug · NDA
Juxtapid (lomitapide mesylate) NDC 76431-110
Lomitapide mesylate 10 mg/1 · Capsule · Oral · Amryt Pharmaceuticals DAC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76431-110-01 | 76431011001 | 28 CAPSULE in 1 BOTTLE (76431-110-01)Marketed from Jan 28, 2013 |
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 — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Amryt Pharmaceuticals DAC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 203858
- Marketing start
- Marketing end
- Other FDA classes
- Cytochrome P450 3A4 Inhibitors (Mechanism)Microsomal Triglyceride Transfer Protein Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 76431-110_76014f22-a52f-486b-a265-177b6403c907SPL ID 76014f22-a52f-486b-a265-177b6403c907SPL set ID e4c45bb5-15f4-437e-ab98-a649b3676d14RxCUI 1364484, 1364490, 1364492, 1364494, 1364496, 1364498, 1648770, 1648772UNII X4S83CP54E
- 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
N476431011001followed by a unit qualifier and the quantityPackage 76431-0110-01. 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)
JUXTAPID is a microsomal triglyceride transfer protein inhibitor indicated as an adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH) ( 1 ). Limitations of Use The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH, including those with heterozygous familial hypercholesterolemia (HeFH) ( 1 ). The effect of JUXTAPID on cardiovascular morbidity and mo…
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 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 |
| Juxtapidlomitapide mesylate | Lomitapide mesylate 30 mg/1 | CapsuleOral | Chiesi USA, Inc. | 10122-430 |