Home NDC 79739-7121 Chenodiol
Product NDC 79739-7121
11-digit product format 797397121
Labeler code 79739
Product ID 79739-7121_d35752ce-bbf7-4690-bf1e-bd024fba85e2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Chenodiol
Dosage form TABLET, FILM COATED
Route ORAL
Labeler LGM Pharma Solutions, LLC
Application ANDA091019
Marketing category ANDA
Marketing start 2009-10-22
Marketing end 0000-00-00
Substance CHENODIOL
Active strength 250 mg/1
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 79739-7121-1 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 79739-7121-1 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 79739-7121-1 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 79739-7121-1 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 79739-7121-1 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 79739-7121-1 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 79739-7121-1 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 79739-7121-1 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 79739-7121-1 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 79739-7121-1 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 79739-7121-1 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 79739-7121-1 I Inactivated by FDA bd6a592717d7…303034d00443…
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…
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 79739-7121-1 Chenodiol 1 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79739-7121 CHENODIOL TABLET, FILM COATED [LGM PHARMA SOLUTIONS, LLC] 2 Legacy NDC, 1 package rows 20230429_d35752ce-bbf7-4690-bf1e-bd024fba85e2.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Chenodal CHENODIOL Travere Therapeutics 769e0a3b-826d-4faf-9129-5eeb7ebe0b67 2025-12-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091019 application number: ANDA091019
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 79739-7121-1 79739712101 1 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (79739-7121-1) 2009-10-22 0000-00-00 No No Current