Home NDC 79378-310 CTEXLI
Product NDC 79378-310
11-digit product format 793780310
Labeler code 79378
Product ID 79378-310_71b050b3-07a6-401f-9526-104383bff7b7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name chenodiol
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mirum Pharmaceuticals Inc.
Application NDA219488
Marketing category NDA
Marketing start 2025-04-04
Substance CHENODIOL
Active strength 250 mg/1
Pharmacologic classes Bile Acid [EPC], Bile Acids and Salts [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N219488-001 CTEXLI CHENODIOL 250MG TABLET / ORAL RLD, RS 2025-02-21
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N219488-001 NP 2028-02-21 N219488-001 ODE-523 2032-02-21
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 2026-08-18 06:07:40 2026-07 N219488-001 CTEXLI 250MG TABLET / ORAL RLD, RS 2025-02-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219488-001 CTEXLI 250MG TABLET / ORAL RLD, RS 2025-02-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219488-001 CTEXLI 250MG TABLET / ORAL RLD, RS 2025-02-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219488-001 CTEXLI 250MG TABLET / ORAL RLD, RS 2025-02-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N219488-001 CTEXLI 250MG TABLET / ORAL RLD, RS 2025-02-21 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219488-001 CTEXLI 250MG TABLET / ORAL RLD, RS 2025-02-21 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-18 06:07:40 2026-07 N219488-001 NP 2028-02-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219488-001 ODE-523 2032-02-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219488-001 NP 2028-02-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219488-001 NP 2028-02-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219488-001 NP 2028-02-21 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219488-001 NP 2028-02-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219488-001 ODE-523 2032-02-21 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base CTEXLI
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHENODIOL 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0GEI24LG0J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 618469 Internal RxNorm lookup 2710422 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 79378-310-90 CTEXLI 100 in 1 BOTTLE TABLET, FILM COATED 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79378-310 CTEXLI (CHENODIOL) TABLET, FILM COATED [MIRUM PHARMACEUTICALS INC.] 1 Current NDC, 1 package rows 20250406_015384e7-4ac5-4782-a309-e40cd1421c5b.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 79378-310-90 79378031090 100 TABLET, FILM COATED in 1 BOTTLE (79378-310-90) 2025-04-04 No No Current