Ursodiol

Product NDC: 50268-796
11-digit product format: 502680796
Labeler code: 50268
Product ID: 50268-796_6e13496f-d95c-eac7-e053-2991aa0aebed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ursodiol
Dosage form: CAPSULE
Route: ORAL
Labeler: AvPAK
Application: ANDA075517
Marketing category: ANDA
Marketing start: 2012-07-25
Marketing end: 0000-00-00
Substance: URSODIOL
Active strength: 300 mg/1
Pharmacologic classes: Bile Acid [EPC],Bile Acids and Salts [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50268-796		D	Discontinued by firm		2026-08-17
excluded package	package	50268-796	50268-796-15	D	Discontinued by firm		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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50268-796-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50268-796-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50268-796-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50268-796-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50268-796-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50268-796-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50268-796-15	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50268-796-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50268-796-15	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50268-796-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50268-796-15	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50268-796-15	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075517-001	URSODIOL	URSODIOL	300MG	CAPSULE / ORAL	AB		2000-03-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075517-001	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 2 · 42 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	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A075517-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075517-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075517-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075517-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075517-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075517-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075517-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075517-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075517-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075517-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075517-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075517-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075517-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075517-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075517-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075517-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075517-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075517-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075517-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075517-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075517-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075517-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075517-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075517-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075517-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075517-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075517-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075517-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075517-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075517-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075517-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075517-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075517-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075517-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075517-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075517-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075517-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075517-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075517-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075517-001	AB	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-796-11	EA - Each	50268-796	a716dd07-0002-42fd-8c08-393617986e95	1	2015-05-05
50268-796-15	EA - Each	50268-796	bfceec2a-6949-4e74-9be5-ccf528c7314d	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
URSODIOL	ACTIVE INGREDIENT	724L30Y2QR	URSODIOL (URSODIOL) CAPSULE [AVPAK]	2
URSODIOL	ACTIVE MOIETY	724L30Y2QR	URSODIOL (URSODIOL) CAPSULE [AVPAK]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	URSODIOL (URSODIOL) CAPSULE [AVPAK]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	URSODIOL (URSODIOL) CAPSULE [AVPAK]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	URSODIOL (URSODIOL) CAPSULE [AVPAK]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	URSODIOL (URSODIOL) CAPSULE [AVPAK]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	URSODIOL (URSODIOL) CAPSULE [AVPAK]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	URSODIOL (URSODIOL) CAPSULE [AVPAK]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	URSODIOL (URSODIOL) CAPSULE [AVPAK]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	URSODIOL (URSODIOL) CAPSULE [AVPAK]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	URSODIOL (URSODIOL) CAPSULE [AVPAK]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	URSODIOL (URSODIOL) CAPSULE [AVPAK]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	URSODIOL (URSODIOL) CAPSULE [AVPAK]	2

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ursodiol	URSODIOL	Major Pharmaceuticals	c9aa0223-3ea4-4cb7-b53b-f35e5a04cec7	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075517 application number: ANDA075517
Ursodiol	URSODIOL	PuraCap Laboratories, LLC	9d7f26d5-d8a9-4610-8d78-80ca3d442a79	2024-12-19	Adverse reactions	Exact identifier application applno (ANDA): 075517 application number: ANDA075517
Ursodiol	URSODIOL	Bryant Ranch Prepack	011ede7f-bb4d-45f7-8041-9feb4aa2ba7d	2023-12-07	Adverse reactions	Exact identifier application applno (ANDA): 075517 application number: ANDA075517
Ursodiol	URSODIOL	Epic Pharma, LLC	e47b49ca-bde9-448a-bf61-f943c2aa5b8e	2023-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075517 application number: ANDA075517
Ursodiol	URSODIOL	PuraCap Laboratories, LLC	4a161c84-141c-4741-8d69-31a6f3dfd18d	2021-10-01	Adverse reactions	Exact identifier application applno (ANDA): 075517 application number: ANDA075517

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
50268-796-15	50268079615	50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-796-15) > 1 CAPSULE in 1 BLISTER PACK (50268-796-11)	50 blister pack	2012-07-25	0000-00-00	No	No	Current