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 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 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.
Product history page 1 of 2 · 42 observed 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 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091019-001 CHENODIOL 250MG TABLET / ORAL RS 2009-10-22 e64feba35796…
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
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 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