Home NDC 68974-876 Chenodal
Product NDC 68974-876
11-digit product format 689740876
Labeler code 68974
Product ID 68974-876_45c74545-e0d8-e34f-e063-6294a90ae857
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chenodiol
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Travere Therapeutics
Application ANDA091019
Marketing category ANDA
Marketing start 2015-12-28
Marketing end 2026-11-30
Substance CHENODIOL
Active strength 250 mg/1
Pharmacologic classes Bile Acid [EPC], Bile Acids and Salts [CS]
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A091019-001 CHENODIOL CHENODIOL 250MG TABLET / ORAL RS 2009-10-22
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 2026-08-01 22:54:32 2026-06 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Chenodal 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 877417 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68974-876-40 Chenodal 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68974-876 CHENODAL (CHENODIOL) TABLET, FILM COATED [TRAVERE THERAPEUTICS] 14 Current NDC, Legacy NDC, 1 package rows 20241210_769e0a3b-826d-4faf-9129-5eeb7ebe0b67.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68974-876-40 68974087640 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68974-876-40) 2015-12-28 2026-11-30 No No Current