Home NDC 50268-864 Ursodiol
Product NDC 50268-864
11-digit product format 502680864
Labeler code 50268
Product ID 50268-864_5797b1d5-e686-ba35-e063-6294a90adae6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ursodiol
Dosage form CAPSULE
Route ORAL
Labeler AvPAK
Application ANDA214295
Marketing category ANDA
Marketing start 2026-07-14
Substance URSODIOL
Active strength 300 mg/1
Pharmacologic classes Bile Acid [EPC]; Bile Acids and Salts [CS]
Listing certified through 2027-12-31
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 A214295-001 URSODIOL URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214295-001 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 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 8869cabd3fbd…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214295-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-10-16 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Ursodiol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength URSODIOL 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 724L30Y2QR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 858747 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 3 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Status 50268-864-13 50268086413 30 BLISTER PACK in 1 BOX (50268-864-13) / 1 CAPSULE in 1 BLISTER PACK (50268-864-11) 30 blister pack 2026-07-14 0 Current