Ursodiol

Product NDC: 50268-864
Requested package NDC: 50268-864-13
11-digit product format: 502680864
Labeler code: 50268
Product ID: 50268-864_5797b1d5-e686-ba35-e063-6294a90adae6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ursodiol
Dosage form: CAPSULE
Route: ORAL
Labeler: AvPAK
Application: ANDA214295
Marketing category: ANDA
Marketing start: 2026-07-14
Substance: URSODIOL
Active strength: 300 mg/1
Pharmacologic classes: Bile Acid [EPC]; Bile Acids and Salts [CS]
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A214295-001	URSODIOL	URSODIOL	300MG	CAPSULE / ORAL	AB		2020-10-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214295-001	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	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214295-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2020-10-16	`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	A214295-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214295-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214295-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214295-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214295-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214295-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214295-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214295-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214295-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214295-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214295-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214295-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214295-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214295-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214295-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214295-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214295-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214295-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214295-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214295-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214295-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A214295-001	AB	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214295-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214295-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214295-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214295-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214295-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214295-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214295-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214295-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214295-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214295-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214295-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214295-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214295-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214295-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Ursodiol
Listing expiration: 2027-12-31

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
5693d709-e894-0144-e063-6294a90a99db	Available on FDA.report

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	AvPAK	5693d709-e894-0144-e063-6294a90a99db	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214295 application number: ANDA214295 ndc (package): 50268-864-13 ndc (product): 50268-864 ndc11 (package): 50268086413
Ursodiol	URSODIOL	Zydus Pharmaceuticals (USA) Inc.	47beccad-d217-4ae5-9d57-79bf8d0704d8	2024-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214295 application number: ANDA214295
Ursodiol	URSODIOL	Zydus Lifesciences Limited	6163fc42-5910-4e19-9e32-3d8e81f50128	2024-02-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214295 application number: ANDA214295

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	Sample	Status
50268-864-13	50268086413	30 BLISTER PACK in 1 BOX (50268-864-13) / 1 CAPSULE in 1 BLISTER PACK (50268-864-11)	30 blister pack	2026-07-14	0	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ursodiol Capsules, USP Rx only Prescribing Information	AvPAK	2026-07-27	HUMAN PRESCRIPTION DRUG LABEL	2