Home NDC 0023-6145 Actigall
Product NDC 0023-6145
11-digit product format 000236145
Labeler code 0023
Product ID 0023-6145_9235c1d8-4038-475c-9962-bbf988d600c7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ursodiol
Dosage form CAPSULE
Route ORAL
Labeler Allergan, Inc.
Application NDA019594
Marketing category NDA
Marketing start 1987-12-31
Marketing end 2021-09-30
Substance URSODIOL
Active strength 300 mg/1
Pharmacologic classes Bile Acid [EPC],Bile Acids and Salts [CS]
NDC exclude flag No
Listing certified through 0000-00-00
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 Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0023-6145-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0023-6145-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0023-6145-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0023-6145-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0023-6145-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0023-6145-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0023-6145-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0023-6145-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0023-6145-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0023-6145-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0023-6145-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0023-6145-01 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019594-001 ACTIGALL URSODIOL 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL 1987-12-31 N019594-002 ACTIGALL URSODIOL 300MG CAPSULE / ORAL AB RLD, RS 1987-12-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019594-002 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 3 · 84 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 N019594-001 ACTIGALL 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL 1987-12-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019594-002 ACTIGALL 300MG CAPSULE / ORAL AB RLD, RS 1987-12-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019594-001 ACTIGALL 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL 1987-12-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019594-002 ACTIGALL 300MG CAPSULE / ORAL AB RLD, RS 1987-12-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019594-001 ACTIGALL 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL 1987-12-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019594-002 ACTIGALL 300MG CAPSULE / ORAL AB RLD, RS 1987-12-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019594-001 ACTIGALL 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL 1987-12-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019594-002 ACTIGALL 300MG CAPSULE / ORAL AB RLD, RS 1987-12-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019594-001 ACTIGALL 150MG CAPSULE / ORAL 1987-12-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019594-002 ACTIGALL 300MG CAPSULE / ORAL AB RLD, RS 1987-12-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019594-001 ACTIGALL 150MG CAPSULE / ORAL 1987-12-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019594-002 ACTIGALL 300MG CAPSULE / ORAL AB RLD, RS 1987-12-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019594-001 ACTIGALL 150MG CAPSULE / ORAL 1987-12-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019594-002 ACTIGALL 300MG CAPSULE / ORAL AB RLD, RS 1987-12-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019594-001 ACTIGALL 150MG CAPSULE / ORAL 1987-12-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019594-002 ACTIGALL 300MG CAPSULE / ORAL AB RLD, RS 1987-12-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019594-001 ACTIGALL 150MG CAPSULE / ORAL 1987-12-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019594-002 ACTIGALL 300MG CAPSULE / ORAL AB RLD, RS 1987-12-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019594-001 ACTIGALL 150MG CAPSULE / ORAL 1987-12-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019594-002 ACTIGALL 300MG CAPSULE / ORAL AB RLD, RS 1987-12-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019594-001 ACTIGALL 150MG CAPSULE / ORAL 1987-12-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019594-002 ACTIGALL 300MG CAPSULE / ORAL AB RLD, RS 1987-12-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019594-001 ACTIGALL 150MG CAPSULE / ORAL 1987-12-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019594-002 ACTIGALL 300MG CAPSULE / ORAL AB RLD, RS 1987-12-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019594-001 ACTIGALL 150MG CAPSULE / ORAL 1987-12-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019594-002 ACTIGALL 300MG CAPSULE / ORAL AB RLD, RS 1987-12-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019594-001 ACTIGALL 150MG CAPSULE / ORAL 1987-12-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019594-002 ACTIGALL 300MG CAPSULE / ORAL AB RLD, RS 1987-12-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019594-001 ACTIGALL 150MG CAPSULE / ORAL 1987-12-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N019594-002 ACTIGALL 300MG CAPSULE / ORAL AB RLD, RS 1987-12-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019594-001 ACTIGALL 150MG CAPSULE / ORAL 1987-12-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019594-002 ACTIGALL 300MG CAPSULE / ORAL AB RLD, RS 1987-12-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019594-001 ACTIGALL 150MG CAPSULE / ORAL 1987-12-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N019594-002 ACTIGALL 300MG CAPSULE / ORAL AB RLD, RS 1987-12-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019594-001 ACTIGALL 150MG CAPSULE / ORAL 1987-12-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N019594-002 ACTIGALL 300MG CAPSULE / ORAL AB RLD, RS 1987-12-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019594-001 ACTIGALL 150MG CAPSULE / ORAL 1987-12-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019594-002 ACTIGALL 300MG CAPSULE / ORAL AB RLD, RS 1987-12-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019594-001 ACTIGALL 150MG CAPSULE / ORAL 1987-12-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019594-002 ACTIGALL 300MG CAPSULE / ORAL AB RLD, RS 1987-12-31 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0023-6145-01 00023614501 100 CAPSULE in 1 BOTTLE (0023-6145-01) 100 capsule 1987-12-31 2021-09-30 No No Current