Ursodiol

Product NDC: 0591-3005
11-digit product format: 005913005
Labeler code: 0591
Product ID: 0591-3005_3ca902a9-d8c3-4c4b-a49f-efc62cf2028a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ursodiol
Dosage form: TABLET
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: NDA020675
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 1997-12-10
Marketing end: 2026-05-31
Substance: URSODIOL
Active strength: 500 mg/1
Pharmacologic classes: Bile Acid [EPC], Bile Acids and Salts [CS]
NDC exclude flag: No
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0591-3005		D	Discontinued by firm		2026-08-17
excluded package	package	0591-3005	0591-3005-01	D	Discontinued by firm		2026-08-17

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
N020675-001	URSO 250	URSODIOL	250MG	TABLET / ORAL		RLD	1997-12-10
N020675-002	URSO FORTE	URSODIOL	500MG	TABLET / ORAL		RLD	2004-07-21

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	N020675-001	URSO 250	250MG	TABLET / ORAL		RLD	1997-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020675-002	URSO FORTE	500MG	TABLET / ORAL		RLD	2004-07-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020675-001	URSO 250	250MG	TABLET / ORAL		RLD	1997-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020675-002	URSO FORTE	500MG	TABLET / ORAL		RLD	2004-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020675-001	URSO 250	250MG	TABLET / ORAL		RLD	1997-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020675-002	URSO FORTE	500MG	TABLET / ORAL		RLD	2004-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020675-001	URSO 250	250MG	TABLET / ORAL		RLD	1997-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020675-002	URSO FORTE	500MG	TABLET / ORAL		RLD	2004-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020675-001	URSO 250	250MG	TABLET / ORAL	AB	RLD	1997-12-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020675-002	URSO FORTE	500MG	TABLET / ORAL	AB	RLD, RS	2004-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020675-001	URSO 250	250MG	TABLET / ORAL	AB	RLD	1997-12-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020675-002	URSO FORTE	500MG	TABLET / ORAL	AB	RLD, RS	2004-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020675-001	URSO 250	250MG	TABLET / ORAL	AB	RLD	1997-12-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020675-002	URSO FORTE	500MG	TABLET / ORAL	AB	RLD, RS	2004-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020675-001	URSO 250	250MG	TABLET / ORAL	AB	RLD	1997-12-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020675-002	URSO FORTE	500MG	TABLET / ORAL	AB	RLD, RS	2004-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020675-001	URSO 250	250MG	TABLET / ORAL	AB	RLD	1997-12-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020675-002	URSO FORTE	500MG	TABLET / ORAL	AB	RLD, RS	2004-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020675-001	URSO 250	250MG	TABLET / ORAL	AB	RLD	1997-12-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020675-002	URSO FORTE	500MG	TABLET / ORAL	AB	RLD, RS	2004-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020675-001	URSO 250	250MG	TABLET / ORAL	AB	RLD	1997-12-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020675-002	URSO FORTE	500MG	TABLET / ORAL	AB	RLD, RS	2004-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020675-001	URSO 250	250MG	TABLET / ORAL	AB	RLD	1997-12-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020675-002	URSO FORTE	500MG	TABLET / ORAL	AB	RLD, RS	2004-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020675-001	URSO 250	250MG	TABLET / ORAL	AB	RLD	1997-12-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020675-002	URSO FORTE	500MG	TABLET / ORAL	AB	RLD, RS	2004-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020675-001	URSO 250	250MG	TABLET / ORAL	AB	RLD	1997-12-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020675-002	URSO FORTE	500MG	TABLET / ORAL	AB	RLD, RS	2004-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020675-001	URSO 250	250MG	TABLET / ORAL	AB	RLD	1997-12-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020675-002	URSO FORTE	500MG	TABLET / ORAL	AB	RLD, RS	2004-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020675-001	URSO 250	250MG	TABLET / ORAL	AB	RLD	1997-12-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020675-002	URSO FORTE	500MG	TABLET / ORAL	AB	RLD, RS	2004-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020675-001	URSO 250	250MG	TABLET / ORAL	AB	RLD	1997-12-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020675-002	URSO FORTE	500MG	TABLET / ORAL	AB	RLD, RS	2004-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020675-001	URSO 250	250MG	TABLET / ORAL	AB	RLD	1997-12-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020675-002	URSO FORTE	500MG	TABLET / ORAL	AB	RLD, RS	2004-07-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020675-001	URSO 250	250MG	TABLET / ORAL	AB	RLD	1997-12-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020675-002	URSO FORTE	500MG	TABLET / ORAL	AB	RLD, RS	2004-07-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020675-001	URSO 250	250MG	TABLET / ORAL	AB	RLD	1997-12-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020675-002	URSO FORTE	500MG	TABLET / ORAL	AB	RLD, RS	2004-07-21	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020675-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020675-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020675-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020675-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020675-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020675-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020675-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020675-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020675-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020675-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020675-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020675-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020675-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020675-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020675-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020675-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020675-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020675-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020675-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020675-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020675-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020675-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020675-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020675-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020675-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020675-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020675-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020675-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020675-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020675-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020675-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020675-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020675-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020675-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020675-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020675-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020675-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020675-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020675-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020675-002	AB	1	`8869cabd3fbd…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1ab35ce6-695f-4d1d-43b4-c16fd63c1674	Product name	3	20250317
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
74e0d644-a165-40ec-b881-1b01c8aa68a4	Product name	1	20201006
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
24881a03-c677-697f-03b9-66e93689fade	Product name	2	20180724
5eb9f24b-9328-475e-af0a-18021935eb6a	Product name	1	20180220
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0591-3005-01	Ursodiol	100 in 1 BOTTLE	TABLET	100		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-3005-01	EA - Each	0591-3005	074417d8-6796-48da-a7f8-9b7612a5cee4	1	2015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
URSODIOL	ACTIVE INGREDIENT	724L30Y2QR	URSODIOL TABLET [ACTAVIS PHARMA, INC.]	2
URSODIOL	ACTIVE MOIETY	724L30Y2QR	URSODIOL TABLET [ACTAVIS PHARMA, INC.]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	URSODIOL TABLET [ACTAVIS PHARMA, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	URSODIOL TABLET [ACTAVIS PHARMA, INC.]	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	URSODIOL TABLET [ACTAVIS PHARMA, INC.]	2
DIBUTYL SEBACATE	INACTIVE INGREDIENT	4W5IH7FLNY	URSODIOL TABLET [ACTAVIS PHARMA, INC.]	2
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	URSODIOL TABLET [ACTAVIS PHARMA, INC.]	2
HYDROGEN PEROXIDE	INACTIVE INGREDIENT	BBX060AN9V	URSODIOL TABLET [ACTAVIS PHARMA, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	URSODIOL TABLET [ACTAVIS PHARMA, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	URSODIOL TABLET [ACTAVIS PHARMA, INC.]	2
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	URSODIOL TABLET [ACTAVIS PHARMA, INC.]	2
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	URSODIOL TABLET [ACTAVIS PHARMA, INC.]	2
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	URSODIOL TABLET [ACTAVIS PHARMA, INC.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	URSODIOL TABLET [ACTAVIS PHARMA, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	URSODIOL TABLET [ACTAVIS PHARMA, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-3005	URSODIOL TABLET [ACTAVIS PHARMA, INC.]	8	Current NDC, Legacy NDC, 1 package rows	20241011_0a7c1ae6-4878-43e7-9026-073f74af64c0.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Urso 250	URSODIOL	Allergan, Inc.	e8fc4fc2-fe5c-4cba-b6e0-5ceaf2157a61	2023-01-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020675 application number: NDA020675

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
724L30Y2QR	URSODIOL	128-13-2	URSODIOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-3005-01	00591300501	100 TABLET in 1 BOTTLE (0591-3005-01)	100 tablet	1997-12-10	2026-05-31	No	No	Current