Ursodiol

Product NDC: 71930-015
11-digit product format: 719300015
Labeler code: 71930
Product ID: 71930-015_c98d6217-b305-4615-9c70-7259d94ca205
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ursodiol
Dosage form: CAPSULE
Route: ORAL
Labeler: Eywa Pharma Inc
Application: ANDA212452
Marketing category: ANDA
Marketing start: 2020-02-05
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: 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	71930-015		D	Discontinued by firm		2026-08-07
excluded package	package	71930-015	71930-015-12	D	Discontinued by firm		2026-08-07

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A212452-001	URSODIOL	URSODIOL	300MG	CAPSULE / ORAL	AB		2019-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212452-001	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
2026-02-19 14:30 UTC	2026-02	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212452-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212452-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212452-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212452-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212452-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212452-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212452-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212452-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212452-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212452-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212452-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212452-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212452-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212452-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212452-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212452-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212452-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212452-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212452-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212452-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212452-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212452-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212452-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212452-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212452-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212452-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212452-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212452-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212452-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212452-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212452-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212452-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212452-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212452-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212452-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212452-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212452-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212452-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212452-001	AB	1	`a50c72e98297…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71930-015-12	EA - Each	71930-015	1bc3d22d-1c8b-423a-8e9f-d08321446287	1	2020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71930-015	URSODIOL CAPSULE [EYWA PHARMA INC]	3	Legacy NDC	20231216_c98d6217-b305-4615-9c70-7259d94ca205.zip

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
71930-015-12	71930001512	100 CAPSULE in 1 BOTTLE (71930-015-12)	100 capsule	2020-02-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ursodiol Capsules, USP Rx Only Prescribing Information	PD-Rx Pharmaceuticals, Inc.	2026-02-17	HUMAN PRESCRIPTION DRUG LABEL	7
Ursodiol Capsules, USP Rx Only Prescribing Information	Eywa Pharma Inc \| Recipharm Pharmaservices Private Limited	2026-01-22	Human Prescription Drug Label	4
Ursodiol Capsules, USP Rx Only Prescribing Information	Bryant Ranch Prepack	2024-04-03	HUMAN PRESCRIPTION DRUG LABEL	102
Ursodiol Capsules, USP Rx Only Prescribing Information	Bryant Ranch Prepack	2024-04-02	HUMAN PRESCRIPTION DRUG LABEL	4