Home NDC 10135-543 Ursodiol
Product NDC 10135-543
11-digit product format 101350543
Labeler code 10135
Product ID 10135-543_445ce602-e08a-4b6d-abfb-9e7f51ff711a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ursodiol
Dosage form CAPSULE
Route ORAL
Labeler Marlex Pharmaceuticals Inc
Application ANDA079082
Marketing category ANDA
Marketing start 2014-10-01
Marketing end 0000-00-00
Substance URSODIOL
Active strength 300 mg/1
Pharmacologic classes Bile Acid [EPC],Bile Acids and Salts [CS]
NDC exclude flag E
Listing certified through 2017-12-31
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 · 44 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 10135-543-01 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 10135-543-01 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 10135-543-01 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 10135-543-01 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 10135-543-01 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 10135-543-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 10135-543-01 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 10135-543-01 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 10135-543-01 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 10135-543-01 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 10135-543-01 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 10135-543-01 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 10135-543-01 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 10135-543-01 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 10135-543-01 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…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 10135-543-01 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 10135-543-01 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 10135-543-01 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 10135-543-01 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 10135-543-01 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 10135-543-01 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 10135-543-01 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 A079082-001 URSODIOL URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A079082-001 AB
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 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A079082-001 URSODIOL 300MG CAPSULE / ORAL AB 2008-12-15 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 10135-543-01 Ursodiol 100 in 1 BOTTLE CAPSULE 100 2
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10135-543 URSODIOL CAPSULE [MARLEX PHARMACEUTICALS INC] 2 Legacy NDC, 1 package rows 20150326_b636694a-26af-4ed2-8b77-197e82a46de7.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 10135-543-01 10135054301 100 in 1 BOTTLE Historical