URSOLIGN

Product NDC: 81279-130
11-digit product format: 812790130
Labeler code: 81279
Product ID: 81279-130_5e248968-a19d-4b59-9873-fba89f6b7fb1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ursodiol
Dosage form: CAPSULE
Route: ORAL
Labeler: Pangea Pharmaceuticals, LLC
Application: ANDA210344
Marketing category: ANDA
Marketing start: 2026-06-15
Substance: URSODIOL
Active strength: 150 mg/1
Pharmacologic classes: Bile Acid [EPC], Bile Acids and Salts [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210344-001	URSODIOL	URSODIOL	300MG	CAPSULE / ORAL	AB		2021-01-22
A210344-002	URSODIOL	URSODIOL	150MG	CAPSULE / ORAL			2026-01-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210344-001	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 · 41 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	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210344-002	URSODIOL	150MG	CAPSULE / ORAL		2026-01-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210344-002	URSODIOL	150MG	CAPSULE / ORAL		2026-01-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210344-002	URSODIOL	150MG	CAPSULE / ORAL		2026-01-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A210344-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210344-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210344-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210344-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210344-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210344-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210344-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210344-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210344-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210344-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210344-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210344-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210344-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210344-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210344-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210344-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210344-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210344-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210344-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210344-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210344-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210344-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210344-001	AB	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210344-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210344-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210344-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210344-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210344-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210344-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210344-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210344-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210344-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210344-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210344-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210344-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210344-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210344-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
URSODIOL	150 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
858331	Internal RxNorm lookup
2745304	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
3617fb7a-1f57-4276-bebb-ae6ba4252d4e	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
URSOLIGN	URSODIOL	Pangea Pharmaceuticals, LLC	3617fb7a-1f57-4276-bebb-ae6ba4252d4e	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210344 application number: ANDA210344 ndc (product): 81279-130
URSODIOL	URSODIOL	Golden State Medical Supply, Inc.	fb317988-a4e3-9c9a-e053-6294a90a5990	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210344 application number: ANDA210344
URSODIOL	URSODIOL	Strides Pharma Science Limited	9a6c1928-2d52-4d9a-8e83-f71892a7e98d	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210344 application number: ANDA210344

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	Exclude flag	Status
81279-130-60	81279013060	60 CAPSULE in 1 BOTTLE (81279-130-60)	60 capsule	2026-06-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
URSOLIGN TM (Ursodiol) Capsules, USP (150 mg) Rx only	Pangea Pharmaceuticals, LLC \| Strides Pharma Global Pte. Ltd. \| Strides Pharma Science Limited	2026-06-12	HUMAN PRESCRIPTION DRUG LABEL	1