Home NDC 64980-483-03 Ursodiol
Product NDC 64980-483
Requested package NDC 64980-483-03
11-digit product format 649800483
Labeler code 64980
Product ID 64980-483_fe8d6ce3-4c51-4b9e-8e1a-90aaf5f2b1a4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ursodiol
Dosage form CAPSULE
Route ORAL
Labeler Rising Pharmaceuticals, Inc.
Application ANDA213200
Marketing category ANDA
Marketing start 2020-02-12
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 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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
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 A213200-001 URSODIOL URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213200-001 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 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213200-001 URSODIOL 300MG CAPSULE / ORAL AB 2020-02-12 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 64980-483-03 64980048303 30 CAPSULE in 1 BOTTLE (64980-483-03) 30 capsule 2020-02-12 0000-00-00 No No Current