Prescription drug · NDA
Livmarli (Maralixibat chloride) NDC 79378-111
Maralixibat chloride 19 mg/mL · Solution · Oral · Mirum Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 79378-111-01 | 79378011101 | 1 BOTTLE in 1 CARTON (79378-111-01) / 30 mL in 1 BOTTLEMarketed from Jul 24, 2024 |
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)
- Livmarli
- Generic name (nonproprietary)
- maralixibat chloride
- Active ingredients
- Maralixibat chloride — 19 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Mirum Pharmaceuticals Inc.NDC labeler code 79378
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214662
- Marketing start
- Listing expires
- Other FDA classes
- Ileal Bile Acid Transporter Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 2B1 Inhibitors (Mechanism)
- Identifiers
- Product ID 79378-111_560d193b-5be5-4799-adfc-f7b36dddd434SPL ID 560d193b-5be5-4799-adfc-f7b36dddd434SPL set ID 64000394-1ef6-4e76-8ba8-11f25ba1b167RxCUI 2571079, 2571085, 2690990, 2690992, 2712463, 2712467, 2712469, 2712471, 2712473, 2712475, 2712477, 2712479UNII V78M04F0XC
- Pharmacologic class
- Ileal Bile Acid Transporter 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
N479378011101followed by a unit qualifier and the quantityPackage 79378-0111-01. 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 .
Indications (excerpt from the label)
LIVMARLI is an ileal bile acid transporter (IBAT) inhibitor indicated for: • the treatment of cholestatic pruritus in patients 3 months of age and older with Alagille syndrome (ALGS). ( 1.1 ) • the treatment of cholestatic pruritus in patients 12 months of age and older with progressive familial intrahepatic cholestasis (PFIC). ( 1.2 ) o Limitations of Use: LIVMARLI is not recommended in a subgroup of PFIC type 2 patients with specific ABCB11 variants resulting in non-functional or complete absence of bile salt export pump (BSEP) protein. ( 14.2 ) 1.1 Treatment of Cholestatic Pruritus in Patients with Alagille Syndrome LIVMARLI ® is indicated for the treatment of cholestatic pruritus in pati…
Excerpt only. Read the full label for complete information.
About NDC 79378-111
- What is NDC 79378-111?
- 79378-111 is the product NDC for Livmarli (maralixibat chloride), Maralixibat chloride 19 mg/mL solution, listed with the FDA by Mirum Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Livmarli (Maralixibat chloride).
- What is the active ingredient?
- Maralixibat chloride.
- Who is the labeler?
- Mirum Pharmaceuticals Inc., NDC labeler code 79378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Livmarli?
- 5 other product NDCs are listed under this name. See all Livmarli NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Livmarli products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Livmarlimaralixibat chloride | Maralixibat chloride 10 mg/1 | TabletOral | Mirum Pharmaceuticals Inc. | 79378-210 | 79378-0210-30 |
| Livmarlimaralixibat chloride | Maralixibat chloride 15 mg/1 | TabletOral | Mirum Pharmaceuticals Inc. | 79378-215 | 79378-0215-30 |
| Livmarlimaralixibat chloride | Maralixibat chloride 20 mg/1 | TabletOral | Mirum Pharmaceuticals Inc. | 79378-220 | 79378-0220-30 |
| Livmarlimaralixibat chloride | Maralixibat chloride 30 mg/1 | TabletOral | Mirum Pharmaceuticals Inc. | 79378-230 | 79378-0230-30 |
| Livmarlimaralixibat chloride | Maralixibat chloride 9.5 mg/mL | SolutionOral | Mirum Pharmaceuticals Inc. | 79378-110 | 79378-0110-01 |
Other NDCs under NDA 214662
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 |
|---|---|---|---|---|
| Livmarlimaralixibat chloride | Maralixibat chloride 9.5 mg/mL | SolutionOral | Mirum Pharmaceuticals Inc. | 79378-110 |