Home NDC 0591-3159-00 Ursodiol
Product NDC 0591-3159
Requested package NDC 0591-3159-00
11-digit product format 005913159
Labeler code 0591
Product ID 0591-3159_0e26efeb-af94-41b0-be24-cf5095f9260e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ursodiol
Dosage form CAPSULE
Route ORAL
Labeler Actavis Pharma, Inc.
Application NDA019594
Marketing category NDA AUTHORIZED GENERIC
Marketing start 1987-12-31
Substance URSODIOL
Active strength 300 mg/1
Pharmacologic classes Bile Acid [EPC], Bile Acids and Salts [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 16 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 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 6db9cb8d1e19…3449e1ec5b70…
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 2026-12-31 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 0591-3159-01 Ursodiol 100 in 1 BOTTLE CAPSULE 100 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded URSODIOL ACTIVE INGREDIENT 724L30Y2QR URSODIOL CAPSULE [ACTAVIS PHARMA, INC.] 6 URSODIOL ACTIVE MOIETY 724L30Y2QR URSODIOL CAPSULE [ACTAVIS PHARMA, INC.] 6 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 URSODIOL CAPSULE [ACTAVIS PHARMA, INC.] 6 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 URSODIOL CAPSULE [ACTAVIS PHARMA, INC.] 6 GELATIN INACTIVE INGREDIENT 2G86QN327L URSODIOL CAPSULE [ACTAVIS PHARMA, INC.] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 URSODIOL CAPSULE [ACTAVIS PHARMA, INC.] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 URSODIOL CAPSULE [ACTAVIS PHARMA, INC.] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ URSODIOL CAPSULE [ACTAVIS PHARMA, INC.] 6 URSODIOL ACTIVE INGREDIENT 724L30Y2QR URSODIOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 URSODIOL ACTIVE MOIETY 724L30Y2QR URSODIOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 URSODIOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 URSODIOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L URSODIOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 URSODIOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 URSODIOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ URSODIOL CAPSULE [CARILION MATERIALS MANAGEMENT] 2 URSODIOL ACTIVE INGREDIENT 724L30Y2QR URSODIOL CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 URSODIOL ACTIVE INGREDIENT 724L30Y2QR URSODIOL CAPSULE [STAT RX USA LLC] 1 URSODIOL ACTIVE INGREDIENT 724L30Y2QR URSODIOL CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 URSODIOL ACTIVE MOIETY 724L30Y2QR URSODIOL CAPSULE [STAT RX USA LLC] 1 URSODIOL ACTIVE MOIETY 724L30Y2QR URSODIOL CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 URSODIOL ACTIVE MOIETY 724L30Y2QR URSODIOL CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 URSODIOL CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 URSODIOL CAPSULE [STAT RX USA LLC] 1 FERRIC OXIDE INACTIVE INGREDIENT 1K09F3G675 URSODIOL CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 FERRIC OXIDE INACTIVE INGREDIENT 1K09F3G675 URSODIOL CAPSULE [STAT RX USA LLC] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 URSODIOL CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 URSODIOL CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 URSODIOL CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 URSODIOL CAPSULE [STAT RX USA LLC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L URSODIOL CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L URSODIOL CAPSULE [STAT RX USA LLC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L URSODIOL CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 URSODIOL CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 URSODIOL CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 URSODIOL CAPSULE [STAT RX USA LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 URSODIOL CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ URSODIOL CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ URSODIOL CAPSULE [STAT RX USA LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ URSODIOL CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-3159 URSODIOL CAPSULE [ACTAVIS PHARMA, INC.] 13 Current NDC, Legacy NDC, 1 package rows 20240612_a061bb07-a85d-4b08-877f-ce02156f0de7.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 Status 0591-3159-00 00591315900 12000 CAPSULE in 1 BOX (0591-3159-00) 12000 capsule 31-DEC-87 Current