Home NDC 42291-923 Ursodiol
Product NDC 42291-923
11-digit product format 422910923
Labeler code 42291
Product ID 42291-923_48bfa576-f7b2-85ff-e063-6394a90a0504
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ursodiol
Dosage form CAPSULE
Route ORAL
Labeler AvKARE
Application NDA019594
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2023-07-18
Substance URSODIOL
Active strength 300 mg/1
Pharmacologic classes Bile Acid [EPC], Bile Acids and Salts [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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Approval date N019594-001 ACTIGALL URSODIOL 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL 1987-12-31 N019594-002 ACTIGALL URSODIOL 300MG CAPSULE / ORAL AB RLD, RS 1987-12-31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N019594-001 ACTIGALL 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL 1987-12-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019594-002 ACTIGALL 300MG CAPSULE / ORAL AB RLD, RS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UTC 2026-02 N019594-001 ACTIGALL 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL 1987-12-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019594-002 ACTIGALL 300MG CAPSULE / ORAL AB RLD, RS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.
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42291-923-01 Ursodiol 100 in 1 BOTTLE CAPSULE 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-923 URSODIOL CAPSULE [AVKARE] 1 Current NDC, 1 package rows 20230719_00c47258-aef0-53f6-e063-6294a90af96f.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 Units Marketing start Sample Exclude flag Status 42291-923-01 42291092301 100 CAPSULE in 1 BOTTLE (42291-923-01) 100 capsule 2023-07-18 No No Current