Ursodiol

Product NDC: 55154-2633
11-digit product format: 551542633
Labeler code: 55154
Product ID: 55154-2633_cc868448-2155-45e6-a13b-72bc0d0f0fc8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ursodiol
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA202540
Marketing category: ANDA
Marketing start: 2024-10-31
Substance: URSODIOL
Active strength: 250 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

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
A202540-001	URSODIOL	URSODIOL	250MG	TABLET / ORAL	AB		2013-02-14
A202540-002	URSODIOL	URSODIOL	500MG	TABLET / ORAL	AB		2013-02-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A202540-001	AB
A202540-002	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202540-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202540-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202540-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202540-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202540-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202540-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202540-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202540-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202540-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202540-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202540-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202540-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202540-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202540-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202540-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202540-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202540-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202540-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202540-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202540-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202540-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202540-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202540-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202540-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202540-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202540-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202540-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202540-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202540-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202540-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202540-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202540-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202540-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202540-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202540-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202540-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202540-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202540-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202540-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202540-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ursodiol
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
URSODIOL	250 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
858751	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
61dcaec8-3acb-4ef0-afde-65a66e99afa7	Available on FDA.report

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
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
55154-2633-0	Ursodiol	10 in 1 BAG	TABLET, FILM COATED	10		3
55154-2633-0	Ursodiol	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55154-2633	URSODIOL TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]	2	Current NDC, 2 package rows	20250326_61dcaec8-3acb-4ef0-afde-65a66e99afa7.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ursodiol	URSODIOL	Bryant Ranch Prepack	f527a42c-a6ec-4a0b-a3d8-6c7eba38733c	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202540 application number: ANDA202540
Ursodiol	URSODIOL	Major Pharmaceuticals	e1f6abfd-2158-4824-b53d-717fbe6de3f9	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202540 application number: ANDA202540
Ursodiol	URSODIOL	Par Health USA, LLC	1a3a8942-94d4-4292-bf74-0a67d92acb90	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202540 application number: ANDA202540
Ursodiol	URSODIOL	AvKARE	0c7e1aa2-704c-435d-e063-6394a90a2d08	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202540 application number: ANDA202540
Ursodiol	URSODIOL	Cardinal Health 107, LLC	61dcaec8-3acb-4ef0-afde-65a66e99afa7	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202540 application number: ANDA202540 ndc (product): 55154-2633
Ursodiol	URSODIOL	Bryant Ranch Prepack	46cfd68f-9a6e-4a00-a3e7-11d130b571fe	2024-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202540 application number: ANDA202540
Ursodiol	URSODIOL	Bryant Ranch Prepack	be811c61-5f48-4b03-94b6-e6941b595621	2024-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202540 application number: ANDA202540
Ursodiol	URSODIOL	Bryant Ranch Prepack	5e6ced5f-b8ef-4e6b-a7c1-730bac650c5b	2023-12-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202540 application number: ANDA202540

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
858751	ursodiol 250 MG Oral Tablet	PSN	61dcaec8-3acb-4ef0-afde-65a66e99afa7	3
858751	ursodiol 250 MG Oral Tablet	SCD	61dcaec8-3acb-4ef0-afde-65a66e99afa7	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55154-2633-0	55154263300	10 BLISTER PACK in 1 BAG (55154-2633-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2024-10-31	No	No	Current