Ursodiol

Product NDC: 0904-7168
11-digit product format: 009047168
Labeler code: 0904
Product ID: 0904-7168_27238e3b-937e-4d18-85b7-0f69bc9e8761
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ursodiol
Dosage form: CAPSULE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA211301
Marketing category: ANDA
Marketing start: 2018-10-22
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: 2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0904-7168		D	Discontinued by firm	2026-10-02
excluded package	package	0904-7168	0904-7168-06	D	Discontinued by firm	2026-10-02
excluded package	package	0904-7168	0904-7168-61	D	Discontinued by firm	2026-10-02

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

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
A211301-001	URSODIOL	URSODIOL	300MG	CAPSULE / ORAL			2018-10-16

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 · 43 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
2026-09-14 22:38:34	2026-08	A211301-001	URSODIOL	300MG	CAPSULE / ORAL		2018-10-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211301-001	URSODIOL	300MG	CAPSULE / ORAL		2018-10-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211301-001	URSODIOL	300MG	CAPSULE / ORAL		2018-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211301-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2018-10-16	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211301-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211301-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211301-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211301-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211301-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211301-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211301-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211301-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211301-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211301-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211301-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211301-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211301-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211301-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211301-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211301-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211301-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211301-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211301-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211301-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211301-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211301-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211301-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211301-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211301-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211301-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211301-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211301-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211301-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211301-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211301-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211301-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211301-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211301-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211301-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211301-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211301-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211301-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211301-001	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1ab35ce6-695f-4d1d-43b4-c16fd63c1674	Product name	3	20250317
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
74e0d644-a165-40ec-b881-1b01c8aa68a4	Product name	1	20201006
24881a03-c677-697f-03b9-66e93689fade	Product name	2	20180724

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7168-06	EA - Each	0904-7168	196d166e-a6ed-4d1d-b6df-06798c7ce42e	1	2022-02-07
0904-7168-61	EA - Each	0904-7168	6c3ff6c3-8e34-435b-81c2-3143766aa063	1	2022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7168	URSODIOL CAPSULE [MAJOR PHARMACEUTICALS]	4	Legacy NDC	20250119_27238e3b-937e-4d18-85b7-0f69bc9e8761.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ursodiol	URSODIOL	AvPAK	bbb1f297-1536-9550-e053-2995a90a0d41	2026-01-12	Adverse reactions	Exact identifier application applno (ANDA): 211301 application number: ANDA211301
Ursodiol	URSODIOL	Amneal Pharmaceuticals NY LLC	1027b933-f64f-4a43-996f-a676b5f72da0	2025-04-24	Adverse reactions	Exact identifier application applno (ANDA): 211301 application number: ANDA211301

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
0904-7168-06	00904716806	50 BLISTER PACK in 1 CARTON (0904-7168-06) > 1 CAPSULE in 1 BLISTER PACK	50 blister pack	2018-10-22	0000-00-00	No	No	Current
0904-7168-61	00904716861	100 BLISTER PACK in 1 CARTON (0904-7168-61) > 1 CAPSULE in 1 BLISTER PACK	100 blister pack	2018-10-22	0000-00-00	No	No	Current