Ursodiol

Product NDC: 59651-421
Requested package NDC: 59651-421-11
11-digit product format: 596510421
Labeler code: 59651
Product ID: 59651-421_7b7addad-c6a5-4570-983f-be62a87e0592
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ursodiol
Dosage form: CAPSULE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA214849
Marketing category: ANDA
Marketing start: 2022-11-28
Substance: URSODIOL
Active strength: 300 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

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
unfinished package	package	59651-421	59651-421-11	UNFINISHED	Active or certified unfinished drug listing		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 · 14 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 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`

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
A214849-001	URSODIOL	URSODIOL	300MG	CAPSULE / ORAL	AB		2022-11-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214849-001	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.

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	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214849-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214849-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214849-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214849-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214849-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214849-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214849-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214849-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214849-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214849-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214849-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214849-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214849-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214849-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214849-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214849-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214849-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214849-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214849-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214849-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214849-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214849-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214849-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214849-001	AB	1	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214849-001	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
URSODIOL	300 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
858747	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
631339fc-548d-4cd5-8cf3-60e1590f79f6	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59651-421-01	Ursodiol	100 in 1 BOTTLE	CAPSULE	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59651-421-01	EA - Each	59651-421	436e5441-7849-4611-8c54-a61dc801db72	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59651-421	URSODIOL CAPSULE [AUROBINDO PHARMA LIMITED]	2	Current NDC, Legacy NDC, 1 package rows	20230911_631339fc-548d-4cd5-8cf3-60e1590f79f6.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	URSODIOL	Bryant Ranch Prepack	b2605f6a-b72d-4773-8d2c-39acfe81e424	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214849 application number: ANDA214849
Ursodiol	URSODIOL	Aurobindo Pharma Limited	631339fc-548d-4cd5-8cf3-60e1590f79f6	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214849 application number: ANDA214849 ndc (product): 59651-421
Ursodiol	URSODIOL	NorthStar Rx LLC	dd0346e2-5ff3-4208-ad88-d09182684603	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214849 application number: ANDA214849

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
858747	ursodiol 300 MG Oral Capsule	PSN	b2605f6a-b72d-4773-8d2c-39acfe81e424	100
858747	ursodiol 300 MG Oral Capsule	SCD	b2605f6a-b72d-4773-8d2c-39acfe81e424	100
858747	ursodiol 300 MG Oral Capsule	PSN	631339fc-548d-4cd5-8cf3-60e1590f79f6	3
858747	ursodiol 300 MG Oral Capsule	SCD	631339fc-548d-4cd5-8cf3-60e1590f79f6	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
59651-421-11	59651042111	1000 CAPSULE in 1 BAG (59651-421-11)	1000 capsule	28-NOV-22	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ursodiol - Bryant Ranch Prepack	Bryant Ranch Prepack	2026-04-20	HUMAN PRESCRIPTION DRUG LABEL	100
Ursodiol - Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2025-07-01	Human Prescription Drug Label	3