Ursodiol 400 mg

Product NDC: 79739-7144
Requested package NDC: 79739-7144-1
11-digit product format: 797397144
Labeler code: 79739
Product ID: 79739-7144_efdeb26d-50b6-4a2f-886a-fcb59ea7fee0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Usodiol
Dosage form: CAPSULE
Route: ORAL
Labeler: LGM PHARMA SOLUTIONS, LLC
Application: ANDA205789
Marketing category: ANDA
Marketing start: 2020-07-01
Substance: URSODIOL
Active strength: 400 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 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	79739-7144	79739-7144-1	I	Inactivated by FDA		excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A205789-001	URSODIOL	URSODIOL	200MG	CAPSULE / ORAL			2020-05-08
A205789-002	URSODIOL	URSODIOL	400MG	CAPSULE / ORAL			2020-05-08

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 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205789-002	URSODIOL	400MG	CAPSULE / ORAL		2020-05-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205789-002	URSODIOL	400MG	CAPSULE / ORAL		2020-05-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205789-001	URSODIOL	200MG	CAPSULE / ORAL	RS	2020-05-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205789-001	URSODIOL	200MG	CAPSULE / ORAL	RS	2020-05-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205789-001	URSODIOL	200MG	CAPSULE / ORAL	RS	2020-05-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205789-001	URSODIOL	200MG	CAPSULE / ORAL	RS	2020-05-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205789-001	URSODIOL	200MG	CAPSULE / ORAL	RS	2020-05-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205789-001	URSODIOL	200MG	CAPSULE / ORAL	RS	2020-05-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205789-001	URSODIOL	200MG	CAPSULE / ORAL	RS	2020-05-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205789-001	URSODIOL	200MG	CAPSULE / ORAL	RS	2020-05-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205789-001	URSODIOL	200MG	CAPSULE / ORAL	RS	2020-05-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205789-001	URSODIOL	200MG	CAPSULE / ORAL	RS	2020-05-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`bb7c543d1eb4…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Ursodiol 400 mg
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
URSODIOL	400 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
412174	Internal RxNorm lookup
2376942	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
ebaaa3e2-1d80-4b40-b696-88cdd06448e4	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
74e0d644-a165-40ec-b881-1b01c8aa68a4	Product name	1	20201006
24881a03-c677-697f-03b9-66e93689fade	Product name	2	20180724

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
79739-7144-1	2024-04-25	C162847	48780-1	1030e365-2f2f-111a-e063-dadaa90a10e2	Ursodiol Capsule
79739-7144-1	2024-01-30	C162847	48780-1	1030e365-2f2f-111a-e063-dadaa90a10e2	Ursodiol Capsule

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
79739-7144-1	Ursodiol 400 mg	100 in 1 BOTTLE	CAPSULE	100		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79739-7144	URSODIOL 200 MG (USODIOL) CAPSULE URSODIOL 400 MG (USODIOL) CAPSULE [LGM PHARMA SOLUTIONS, LLC]	3	Current NDC, Legacy NDC, 1 package rows	20241123_ebaaa3e2-1d80-4b40-b696-88cdd06448e4.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ursodiol 200 mg	USODIOL	LGM PHARMA SOLUTIONS, LLC	ebaaa3e2-1d80-4b40-b696-88cdd06448e4	2024-11-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205789 application number: ANDA205789 ndc (package): 79739-7144-1 ndc (product): 79739-7144 ndc11 (package): 79739714401
Ursodiol 200 mg	URSODIOL	FH2 Pharma LLC	476179dc-b410-4305-881b-470511765647	2023-12-31	Adverse reactions	Exact identifier application applno (ANDA): 205789 application number: ANDA205789
Reltone 200 mg	URSODIOL	Intra-Sana Laboratories	d1c28b0b-8f3c-4d60-8182-24a4c659d762	2023-01-16	Adverse reactions	Exact identifier application applno (ANDA): 205789 application number: ANDA205789

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
412174	ursodiol 200 MG Oral Capsule	PSN	ebaaa3e2-1d80-4b40-b696-88cdd06448e4	3
2376942	ursodiol 400 MG Oral Capsule	PSN	ebaaa3e2-1d80-4b40-b696-88cdd06448e4	3
412174	ursodiol 200 MG Oral Capsule	SCD	ebaaa3e2-1d80-4b40-b696-88cdd06448e4	3
2376942	ursodiol 400 MG Oral Capsule	SCD	ebaaa3e2-1d80-4b40-b696-88cdd06448e4	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
79739-7144-1	79739714401	100 CAPSULE in 1 BOTTLE (79739-7144-1)	100 capsule	2020-07-01	0000-00-00	No	No	Current