Prescription drug · NDA
Lynavoy (Linerixibat) NDC 69516-140
Linerixibat 40 mg/1 · Tablet, Film coated · Oral · Intercept Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69516-140-60 | 69516014060 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69516-140-60)Marketed from Jun 11, 2026 |
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)
- Lynavoy
- Generic name (nonproprietary)
- linerixibat
- Active ingredients
- Linerixibat — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Intercept Pharmaceuticals IncNDC labeler code 69516
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 220295
- Marketing start
- Listing expires
- Other FDA classes
- Ileal Bile Acid Transporter Inhibitors (Mechanism)
- Identifiers
- Product ID 69516-140_634f5ee8-336b-42a6-b481-db1c28bae053SPL ID 634f5ee8-336b-42a6-b481-db1c28bae053SPL set ID c00317c8-709c-4707-a6d1-632bff123026RxCUI 2745144, 2745150UNII 386012Z45SUPC 0369516140601
- 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
N469516014060followed by a unit qualifier and the quantityPackage 69516-0140-60. 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)
LYNAVOY is indicated for the treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC) in adult patients. Limitations of Use Avoid use of LYNAVOY in patients with decompensated cirrhosis or those with prior or active hepatic decompensation events (e.g. variceal hemorrhage, ascites, hepatic encephalopathy) [see Use in Specific Populations (8.7) , Clinical Pharmacology (12.3) ] . LYNAVOY is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC) in adult patients. ( 1 ) Limitations of Use Avoid use of LYNAVOY in patients with decompensated cirrhosis or those with prior or act…
Excerpt only. Read the full label for complete information.
About NDC 69516-140
- What is NDC 69516-140?
- 69516-140 is the product NDC for Lynavoy (linerixibat), Linerixibat 40 mg/1 tablet, film coated, listed with the FDA by Intercept Pharmaceuticals Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lynavoy (Linerixibat).
- What is the active ingredient?
- Linerixibat.
- Who is the labeler?
- Intercept Pharmaceuticals Inc, NDC labeler code 69516. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lynavoy?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.