Ursodiol 400 mg

Product NDC: 0722-7144
Requested package NDC: 0722-7144-01
11-digit product format: 007227144
Labeler code: 0722
Product ID: 0722-7144_4c90708e-d895-44c4-8ba2-88478fe2e01b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Usodiol
Dosage form: CAPSULE
Route: ORAL
Labeler: Nexgen Pharma, Inc
Application: ANDA205789
Marketing category: ANDA
Marketing start: 2020-07-01
Marketing end: 0000-00-00
Substance: URSODIOL
Active strength: 400 mg/1
Pharmacologic classes: Bile Acid [EPC],Bile Acids and Salts [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0722-7144	0722-7144-01	I	Inactivated by FDA		2026-08-17

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 · 19 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 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	`8dfbde2a14a4…`	`c9ff85d89658…`

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
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 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 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…`
2021-12-28 21:50 UTC	2021-12	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`782e0a99824c…`

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
0722-7144-01	2021-07-23	C162847	48780-1	c7ccaba7-2940-fd44-e053-dadaa90aa01b	Ursodiol Capsules, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0722-7144-01	Ursodiol 400 mg	100 in 1 BOTTLE	CAPSULE	100		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0722-7144	URSODIOL 200 MG (USODIOL) CAPSULE URSODIOL 400 MG (USODIOL) CAPSULE [NEXGEN PHARMA, INC]	5	Legacy NDC, 1 package rows	20200701_a0289352-0e73-41d9-9480-a8c2ff5dbf12.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
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	a0289352-0e73-41d9-9480-a8c2ff5dbf12	5
2376942	ursodiol 400 MG Oral Capsule	PSN	a0289352-0e73-41d9-9480-a8c2ff5dbf12	5
412174	ursodiol 200 MG Oral Capsule	SCD	a0289352-0e73-41d9-9480-a8c2ff5dbf12	5
2376942	ursodiol 400 MG Oral Capsule	SCD	a0289352-0e73-41d9-9480-a8c2ff5dbf12	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0722-7144-01	00722714401	100 CAPSULE in 1 BOTTLE (0722-7144-01)	100 capsule	2020-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ursodiol Capsules, USP Rx Only	Nexgen Pharma, Inc \| Nexgen Pharma, Inc.	2020-05-15	HUMAN PRESCRIPTION DRUG LABEL	5