Home NDC 69516-140 Lynavoy
Product NDC 69516-140
11-digit product format 695160140
Labeler code 69516
Product ID 69516-140_634f5ee8-336b-42a6-b481-db1c28bae053
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Linerixibat
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Intercept Pharmaceuticals Inc
Application NDA220295
Marketing category NDA
Marketing start 2026-06-11
Substance LINERIXIBAT
Active strength 40 mg/1
Pharmacologic classes Ileal Bile Acid Transporter Inhibitor [EPC], Ileal Bile Acid Transporter Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N220295-001 LYNAVOY LINERIXIBAT 40MG TABLET / ORAL RLD, RS 2026-03-17
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N220295-001 9040518 2031-09-06 Drug substance, Drug product 2026-04-06
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N220295-001 NCE 2031-03-17 N220295-001 ODE-517 2033-03-17
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N220295-001 LYNAVOY 40MG TABLET / ORAL RLD, RS 2026-03-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N220295-001 LYNAVOY 40MG TABLET / ORAL RLD, RS 2026-03-17 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220295-001 LYNAVOY 40MG TABLET / ORAL RLD, RS 2026-03-17 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N220295-001 9040518 2031-09-06 Drug substance, Drug product 2026-04-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 N220295-001 9040518 2031-09-06 Drug substance, Drug product 2026-04-06 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220295-001 9040518 2031-09-06 Drug substance, Drug product 2026-04-06 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-09-14 22:38:34 2026-08 N220295-001 NCE 2031-03-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N220295-001 ODE-517 2033-03-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N220295-001 NCE 2031-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N220295-001 ODE-517 2033-03-17 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220295-001 NCE 2031-03-17 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220295-001 ODE-517 2033-03-17 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Lynavoy
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LINERIXIBAT 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 386012Z45S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2745144 Internal RxNorm lookup 2745150 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 69516-140-60 69516014060 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69516-140-60) 2026-06-11 No No Current