Home NDC 69025-128 Ursodiol
Product NDC 69025-128
11-digit product format 690250128
Labeler code 69025
Product ID 69025-128_c95b11ac-4350-06c5-e053-2a95a90a9054
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ursodiol
Dosage form CAPSULE
Route ORAL
Labeler Aizant Drug Research Solutions Pvt Ltd
Application ANDA214329
Marketing category ANDA
Marketing start 2021-07-28
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 No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 A214329-001 URSODIOL URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214329-001 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.
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 2026-02-19 14:30 UTC 2026-02 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214329-001 URSODIOL 300MG CAPSULE / ORAL 2021-07-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214329-001 URSODIOL 300MG CAPSULE / ORAL 2021-07-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214329-001 URSODIOL 300MG CAPSULE / ORAL 2021-07-28 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214329-001 URSODIOL 300MG CAPSULE / ORAL 2021-07-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214329-001 URSODIOL 300MG CAPSULE / ORAL 2021-07-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214329-001 URSODIOL 300MG CAPSULE / ORAL 2021-07-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214329-001 URSODIOL 300MG CAPSULE / ORAL 2021-07-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214329-001 URSODIOL 300MG CAPSULE / ORAL 2021-07-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214329-001 URSODIOL 300MG CAPSULE / ORAL 2021-07-28 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214329-001 URSODIOL 300MG CAPSULE / ORAL AB 2021-07-28 a50c72e98297…
Observed Orange Book normalized TE history# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69025-128-01 69025012801 100 CAPSULE in 1 BOTTLE, PLASTIC (69025-128-01) 100 capsule 2021-07-28 0000-00-00 No No Current