Ursodiol

Product NDC: 0904-6221
Requested package NDC: 0904-6221-06
11-digit product format: 009046221
Labeler code: 0904
Product ID: 0904-6221_7aace946-7c2a-422f-a905-c6afe5f8327f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ursodiol
Dosage form: CAPSULE
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA075517
Marketing category: ANDA
Marketing start: 2011-04-01
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

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 · 4 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
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A075517-001	URSODIOL	URSODIOL	300MG	CAPSULE / ORAL	AB		2000-03-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075517-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075517-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2000-03-14	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075517-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075517-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075517-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075517-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075517-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075517-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075517-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075517-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075517-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075517-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075517-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075517-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075517-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075517-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075517-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075517-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075517-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075517-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075517-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075517-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075517-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075517-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075517-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075517-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075517-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075517-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075517-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075517-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075517-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075517-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075517-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075517-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075517-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075517-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075517-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075517-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075517-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075517-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075517-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075517-001	AB	1	`e64feba35796…`

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
c9aa0223-3ea4-4cb7-b53b-f35e5a04cec7	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	SPL version
0904-6221-06	Ursodiol	1 in 1 BLISTER PACK	CAPSULE	1	9
0904-6221-06	Ursodiol	50 in 1 CARTON	CAPSULE	50	9
0904-6221-61	Ursodiol	1 in 1 BLISTER PACK	CAPSULE	1	9
0904-6221-61	Ursodiol	100 in 1 CARTON	CAPSULE	100	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6221-06	EA - Each	0904-6221	e1fe6581-5d94-4567-8906-af878f9cf800	1	2017-10-13
0904-6221-60	EA - Each	0904-6221	3fc723fd-f0ba-469f-b2a0-381d93abc937	1	2013-02-13
0904-6221-61	EA - Each	0904-6221	6aafe58d-ea1d-4976-8d40-962e394d7152	1	2017-10-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
URSODIOL	ACTIVE INGREDIENT	724L30Y2QR	URSODIOL CAPSULE [MAJOR PHARMACEUTICALS]	2
URSODIOL	ACTIVE MOIETY	724L30Y2QR	URSODIOL CAPSULE [MAJOR PHARMACEUTICALS]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	URSODIOL CAPSULE [MAJOR PHARMACEUTICALS]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	URSODIOL CAPSULE [MAJOR PHARMACEUTICALS]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	URSODIOL CAPSULE [MAJOR PHARMACEUTICALS]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	URSODIOL CAPSULE [MAJOR PHARMACEUTICALS]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	URSODIOL CAPSULE [MAJOR PHARMACEUTICALS]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	URSODIOL CAPSULE [MAJOR PHARMACEUTICALS]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	URSODIOL CAPSULE [MAJOR PHARMACEUTICALS]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	URSODIOL CAPSULE [MAJOR PHARMACEUTICALS]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	URSODIOL CAPSULE [MAJOR PHARMACEUTICALS]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	URSODIOL CAPSULE [MAJOR PHARMACEUTICALS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	URSODIOL CAPSULE [MAJOR PHARMACEUTICALS]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6221	URSODIOL CAPSULE [MAJOR PHARMACEUTICALS]	9	Current NDC, Legacy NDC, 4 package rows	20250112_c9aa0223-3ea4-4cb7-b53b-f35e5a04cec7.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ursodiol	URSODIOL	Major Pharmaceuticals	c9aa0223-3ea4-4cb7-b53b-f35e5a04cec7	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075517 application number: ANDA075517 ndc (package): 0904-6221-06 ndc (product): 0904-6221 ndc11 (package): 00904622106
Ursodiol	URSODIOL	PuraCap Laboratories, LLC	9d7f26d5-d8a9-4610-8d78-80ca3d442a79	2024-12-19	Adverse reactions	Exact identifier application applno (ANDA): 075517 application number: ANDA075517
Ursodiol	URSODIOL	Bryant Ranch Prepack	011ede7f-bb4d-45f7-8041-9feb4aa2ba7d	2023-12-07	Adverse reactions	Exact identifier application applno (ANDA): 075517 application number: ANDA075517
Ursodiol	URSODIOL	Epic Pharma, LLC	e47b49ca-bde9-448a-bf61-f943c2aa5b8e	2023-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075517 application number: ANDA075517
Ursodiol	URSODIOL	PuraCap Laboratories, LLC	4a161c84-141c-4741-8d69-31a6f3dfd18d	2021-10-01	Adverse reactions	Exact identifier application applno (ANDA): 075517 application number: ANDA075517

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	c9aa0223-3ea4-4cb7-b53b-f35e5a04cec7	9
858747	ursodiol 300 MG Oral Capsule	SCD	c9aa0223-3ea4-4cb7-b53b-f35e5a04cec7	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6221-06	00904622106	50 BLISTER PACK in 1 CARTON (0904-6221-06) / 1 CAPSULE in 1 BLISTER PACK	50 blister pack	2011-04-01	2023-08-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ursodiol Capsules USP, 300 mg Rx only	Major Pharmaceuticals	2025-01-09	HUMAN PRESCRIPTION DRUG LABEL	9
Ursodiol Capsules USP, 300 mg Rx only	Cardinal Health 107, LLC \| Epic Pharma, LLC	2022-11-28	HUMAN PRESCRIPTION DRUG LABEL	2